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U.S. Department of Health and Human Services

Class 2 Device Recall QStress device

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 Class 2 Device Recall QStress devicesee related information
Date Initiated by FirmDecember 08, 2023
Date PostedJanuary 10, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0705-2024
Recall Event ID 93209
510(K)NumberK152944 
Product Classification Electrocardiograph - Product Code DPS
ProductQ-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX: f) QS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1: g) QS6 AM12Q TTL KIT AHA / QS-6AC-XXAXX: h) QS6 AM12Q TTL KIT AHA / QS-6AC-XXBXX: i) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXAXA: j) QS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS: k) QS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA: l) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA: m) QS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA: n) QS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA: o) QS6 AM12Q TTL KIT AHA XML / QS6-MXTCS: p) QS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB: q) QS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA: r) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX: s) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX: t) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX: u) QS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB: v) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA: w) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA: x) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA: y) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA: z) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA: aa) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA: bb) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA: cc) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA: dd) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB: ee) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB: ff) QS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC: gg) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA: hh) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA: ii) QS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA: jj) QS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB: kk) QS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX: ll) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA: mm) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA: nn) QS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX: oo) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB: pp) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB: qq) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX: rr) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA: ss) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX: tt) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX: uu) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA: vv) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA: ww) QS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA: xx) QS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA: yy) QS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB: zz) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB: aaa) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB: bbb) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1: ccc) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA: ddd) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA: eee) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA: fff) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1: ggg) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1: hhh) QS6 AM12QKIT AHA XML / QS-6CC-XXAXA: iii) QS6 AM12QKIT AHA / QS-6CC-XXBXX: jjj) QS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB: kkk) QS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX: lll) QS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX: mmm) QS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX: nnn) QS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA: ooo) QS6 AM12QSYS IEC XML / QS-6CB-CXCXA: ppp) QS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX: qqq) QS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA: rrr) QS6 NOACQMOD KIT NO LDSET XML / QS-6XC-XXXXA: sss) QS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX: ttt) QS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB: uuu) QS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA: vvv) QS6 PRO ENHANCED SECURITY / QS6-STTDX: www)
Code Information a) QS6-BXXCS, UDI/DI 00732094263176, Serial Numbers: 116350524925, 116490541255; b) QS-6CC-DGCXX, UDI/DI 00732094308716, Serial Numbers: 119050000134; c) QS-6CC-DFCXX, UDI/DI 00732094308723, Serial Numbers: 122290000606, 122230001869, 122230001868, 122150001605, 122150001604, 122090000843, 119310001134, 119240000440, 122430000522, 122430000523, 119050000135; d) QS-6JB-AXAXA, UDI/DI 00732094263206, Serial Numbers: 123170000019; e) QS6-BLXCX, UDI/DI 0081234502761721, Serial Numbers: 116090330912, 116100344488, 116100344490, 116140389225, 116150394312, 116180422821, 116180422823, 116210442892, 116220445992, 116230451848, 116230455471, 116260496356, 116310521226, 116310521294, 116310521295, 116340523119, 116370526978, 116400530719, 116500543975, 116520546015, 117090555819, 117120557453, 117240573603, 117240573604, 117240573605, 117240573606, 117250575355, 117250575356, 117310581182, 117320582007, 117330583105, 117330583106, 117420591117, 117480596687, 117510602012, 117520603268, 118020605912, 118040608668, 118050610650, 118180633950, 118180633951, 118250001740, 118210638580, 118360000413, 118360000414, 118360000415, 118400000214, 119090001180, 119170000426, 119200000235, 119250000559, 119350003341, 119350003342, 119400001642, 119400001643, 119390002403, 119450000815, 119470000523, 119470000524, 120190001489, 120340001206, 120370000113, 120390000395, 120450000603, 117380587441, 121040002696, 121320000296, 121400000048, 121420000470; f) QS6-BLXC1, UDI/DI 0081234502760021, Serial Numbers: 116110351990, 116170411313, 116180422820, 116190425267, 116200431781, 116200435830, 116200435832, 116210440257, 116210442845, 116220445031, 116220447262, 116220447261, 116220448956, 116240457509, 116240461442, 116240461206, 116250486048, 116250485976, 116250489753, 116260496350, 116260496357, 116260496358, 116260496359, 116270498882, 116280504766, 116280504767, 116280505422, 116290511314, 116290511315, 116290516779, 116300519942, 116300520698, 116310521231, 116310521175, 116320522055, 116330522666, 116340523645, 116370526300, 116370526302, 116380527090, 116370526980, 116390528637, 116380528395, 116390529243, 116390529244, 116390529289, 116390529290, 116390529245, 116390529246, 116400530260, 116430534181, 116440534647, 116440535722, 116450535995, 116460537454, 116460537582, 116490541890, 116500544101, 116500544003, 116510545088, 116520546283, 116530547307, 116530547308, 116530547309, 116520546501, 116530547394, 117010549346, 117020550273, 117040551450, 117030550903, 117050552567, 117080554660, 117110556288, 117120556595, 117140562002, 117170565229, 117170566105, 117230572559, 117230572529, 117230572792, 117230572972, 117240573048, 117240573453, 117240573579, 117280577601, 117290579316, 117300580356, 117320581836, 117320581837, 117320582120, 117380587062, 117390588108, 117450593979, 117450593976, 117450593977, 117450593978, 117480597797, 117480597798, 117480597583, 117480597584, 117520603269, 117520603562, 118040607784, 118090615610, 118090615611, 118140626430, 118150627079, 118160628175, 118150627075, 118150627074, 118150627073, 118150627072, 118150627071, 118150627070, 118150627069, 118120623174, 118180633959, QS6-BLXC1, 118180634187, 118310001237, 118340000912, 118340000913, 118340000914, 118370000773, 118380001940, 118460001584, 118480000810, 118490000217, 118520000406, 119040000078, 119110000757, 119150000254, 119160000043, 119190000970, 119250000554, 119280001984, 119290000535, 119500001105, 120020000304, 120100001917, 120220001572, 120220001573, 120230001261, 120320000243, 120320000244, 120300000912, 120360001047, 121070000465, 121070001280, 121100002344, 121100002345, 121130001104, 121180000761, 121340000883, 121370002510, 121390000795, 121460001255, 122200001819, 122480002102, 123300001831; g) QS-6AC-XXAXX, UDI/DI 00732094301076, Serial Numbers: 123240000013, 123240000012, 123240000011, 123240000010, 123240000009, 120400002601, 120400002600, 120400002599, 120400002598, 120400002597, 120210000914, 120210000913, 120210000912, 120210000911, 120210000910, 120210000909, 120210000908, 120210000907, 120210000906, 120210000905, 120210000904, 120210000903, 119330001329, 119330001328, 119330001327, 119330001326, 119330001325, 119330001324, 119330001323, 119320001019, 119320001018, 119320001017, 119320001016, 119320001015, 119180001173, 119180001172, 119180001171, 119180001170, 119110000755, 118430000951, 11840000949, 118430000948, 118430000949, 123310000826, 123310000827, 123310000828, 123310000829, 123310000830, 123430000320, 123430000321, 123430000322, 123430000323, 123430000324, 123430000325, 123430000326, 123430000327, 123430000328, 123430000329; h) QS-6AC-XXBXX, UDI/DI 00732094346633, Serial Numbers: 123040001807, 123040001806, 123040001805, 123040001804, 123040001803, 122510000875, 122510000874, 122510000873, 122510000872, 122510000871, 122480001730, 122480001729, 122480001728, 122480001727, 122480001726, 122250001966, 122250001965, 122250001964, 122250001963, 122250001962, 122240000488, 122240000487, 122240000486, 122240000485, 122240000484, 122160000349, 122160000348, 122160000347, 122160000346, 122160000345, 122010000998, 122010000997, 122010000996, 122010000995, 122010000994, 121490000353, 121490000352, 121490000351, 121490000350, 121490000349, 121320000685, 121320000684, 121320000683, 121320000682, 121320000681, 121090000175, 121090000174, 121090000173, 121090000172, 121090000171; i) QS-6AC-XXAXA, UDI/DI 00732094355314, Serial Numbers: 123400000592, 123400000593; j) QS6-AXTDS, UDI/DI 00812345027587, Serial Numbers: 116120372696; k) QS-6AC-AXAAA, UDI/DI 00732094263855, Serial Numbers: 118520000406; l) QS-6AC-CXBXA, UDI/DI 00732094263794, Serial Numbers: 116330522481; m) QS-6AC-DXAXA, UDI/DI 00732094263756, Serial Numbers: 116070309986; n) QS-6AC-XXBXA, UDI/DI 00732094263732, Serial Numbers: 117380586614; o) QS6-MXTCS, UDI/DI 0081234502767921, Serial Numbers: 116150390529, 116210438777, 116530547233, 116530547234, 116530547235; p) QS-6AC-CGAAB, UDI/DI 00732094326604, Serial Numbers: 119470001903; q) QS-6AC-XAAXA, UDI/DI 00732094263749, Serial Numbers: 117280578329; r) QS-6AC-DEAAX, UDI/DI 00732094263787, Serial Numbers: 117120558685; s) QS-6AC-DFAAX, UDI/DI 00732094263763, 117160563895; t) QS-6AC-EEBXX, UDI/DI None, Serial Numbers: 118200636641; u) QS-6AC-CFBAB, UDI/DI 00732094318029, Serial Numbers: 123130002242; v) QS-6AC-CFAAA, UDI/DI 00732094263824, Serial Numbers: 122060000614, 121270000363, 117210570696; w) QS-6AC-CFBAA, UDI/DI 00732094318111, Serial Numbers: 123130000023, 123130000022, 123130000021, 123130000020, 123130000019, 123130000018, 122380000698, 121450000731, 121450000730, 123290000564, 123290000565; x) QS-6AC-DFAAA, UDI/DI 00732094263770, Serial Numbers: 118440001972, 119260000952, 119080001406, 119080001405, 118500002162, 118440001973, 118210638583, 118200636642, 118050610062, 118040608669, 117490599962, 117490599961, 117480597107, 117430591574, 117150562907, 116520546288, 116520546282, 116480540169, 116470539963, 116440534646; y) QS-6AC-DFBAA, UDI/DI 00732094302073, Serial Numbers: 122200000715, 122190000632, 122130001859, 122130001858, 122130001857, 122020001892, 122020000512, 122020000511, 121340000499, 121320001535, 121320000290, 121140001779, 120440000212, 119250000555, 119170000486, 122430000520, 122430000521, 119130000111, 119270000118; z) QS-6AC-AFCXA, UDI/DI 00732094263862, Serial Numbers: 118070613220; aa) QS-6AC-CECAA, UDI/DI 00732094336801, Serial Numbers: 123010001116, 120450001427, 120450001426, 120450001425, 123350000876, 123450001519; bb) QS-6AC-CFCAA, UDI/DI 00732094263817, Serial Numbers: 117290578972; cc) QS-6AC-CFEAA, UDI/DI 00732094263800, Serial Numbers: 117430591575; dd) QS-6AC-ACAAB, UDI/DI 00732094263879, Serial Numbers: 123280000370, 123280000369, 123280000368, 123280000367, 123280000366, 123280000365, 123200001032, 123200001031, 123200001030, 123200001029, 123200001028, 123200001027, 123030001347, 123030001346, 123030001345, 123030001344, 123030001343, 123030001342, 123030001341, 123030001340, 123030001339, 123030001338, 123030001337, 123030001336, 122460001577, 122460001576, 122460001575, 122460001574, 122460001573, 121410001264, 121410001263, 121410001262, 121410001261, 121410001260, 121410001259, 121410001258, 121410001257, 121410001256, 121410001255, 121370000467, 121370000466, 121370000465, 121370000464, 121370000463, 121240001238, 121240001237, 121170000417, 121170000416, 121170000415, 121170000414, 121170000413, 121170000412, 121170000411, 121110000836, 121110000835, 121110000834, 121110000833, 121110000832, 121110000831, 121110000830, 121110000829, 121110000828, 121110000827, 121110000826, 121110000825, 121110000824, 121050000578, 121050000577, 121050000576, 121050000575, 121050000574, 118460000414, 118460000413, 118460000412, 118460000411, 118460000410, 118460000409, 118170632607, 118170632606, 118100617938, 118100617937, 118090616426, 118090616425, 118090616424, 117460595390, 117460595389, 117460595388, 117460595387, 117460595386, 117460595385, 117380587627, 117380587626, 117050553076, 117050553075, 117050553074, 116500544083, 116500544082, 116500544081, 123250001021, 123250001022, 123250001023, 123250001024, 123250001025, 123250001026, 123370000153, 123370000154, 123370000155, 123370000156; ee) QS-6AC-DDBAB, UDI/DI 00732094312966, Serial Numbers: 119350002685, 119100000503; ff) QS-6AC-DDBAC, UDI/DI 00732094312959, Serial Numbers: 119350002686; gg) QS-6AC-CDBXA, UDI/DI 00732094263831, Serial Numbers: 123190000068, 123110001251, 122090001000, 116470538496, 116470538495, 116470538494, 116470538493, 116470538492, 116470538491, 116340523788, 116340523787, 116340523786, 123400000105, 123450000611; hh) QS-6AC-DDBAA, UDI/DI 00732094312973, Serial Numbers: 119350002087, 119100000502; ii) QS-6AB-BXAXA, UDI/DI 00732094263916, Serial Numbers: 116110349242; jj) QS-6AB-CGAAB, UDI/DI 00732094263893, Serial Numbers: 122240001151, 120390000393, 118070613221; kk) QS-6AA-DEAXX, UDI/DI 00732094263923, Serial Numbers: 116190431279, 116190431277, 116190431275, 116190431273, 116190431271, 116190431269; ll) QS-6AB-CEAAA, UDI/DI 00732094263909, Serial Numbers: 119270000108, 119040000856, 117490600126, 123110000500; mm) QS-6AD-AEAAA, UDI/DI 00732094288940, Serial Numbers: 118490000214, 118490000213, 118490000212, 118490000211, 118270000503, 118270000502, 118270000501; nn) QS-6AD-BCAAX, UDI/DI 00732094263718, Serial Numbers: 116230451701; oo) QS-6AA-ACAAB, UDI/DI 00732094263947, Serial Numbers: 119240000738, 115510284694; pp) QS-6AA-DDAAB, UDI/DI 00732094263930, Serial Numbers: 116150390528; qq) QS6-ATTDX, UDI/DI 0081234502757021, Serial Numbers: 116070306098, 116070307281, 116070311291, 116110360656, 116110360658, 116110360660, 116190428764, 116190431265, 116190431268, 116190431239, 116190431241, 116210440023, 116220447275, 116250485174, 116250485959, 116260491968, 116260491970, 116260491972, 116260491974, 116280504761, 116280504768, 116290516786, 116290516812, 116290516813, 116290516815, 116280506964, 116280506966, 116300519873, 116320522168, 116330523070, 116340523725, 116340523726, 116340523727, 116340523728, 116350524962, 116370526231, 116370526235, 116380527225, 116380528397, 116380528398, 116380528399, 116380528400, 116390529085, 116390529086, 116390529087, 116400530261, 116410531492, 116410531499, 116420532365, 116440535274, 116440535550, 116450536751, 116460537578, 116460537579, 116490541737, 116460537577, 116500542854, 116500542855, 116500543269, 116510545083, 116530546706, 116530547125, 116530546705, 116530547310, 116530547262, 116530547263, 117010549347, 117010549348, 117010549349, 117030551222, 117030551223, 117030551224, 117030551198, 117060553621, 117080554650, 117090555978, 117120556692, 117120556693, 117120556669, 117120556938, 117120556939, 117110556361, 117130560356, 117130559722, 117130559723, 117130559724, 117130559725, 117130560366, 117130560907, 117130560908, 117130560909, 117130559206, 117130559207, 117140562692, 117140561999, 117140562000, 117180567011, 117200568668, 117200568669, 117200569177, 117210570093, 117210570094, 117210570095, 117210570736, 117230572508, 117230572509, 117230572795, 117230572796, 117230572797, 117240573777, 117250575370, 117260576146, 117260576380, 117260576147, 117260576521, 117260576907, 117270577366, 117270577367, 117270577369, 117300580355, 117260576919, 117330582978, 117340583701, 117340583700, 117340583703, 117350584566, 117360584806, 117380586443, 117380586438, 117380586439, 117380586440, 117380587063, 117390588206, 117410590220, 117420591116, 117460595235, 117480597799, 117490599957, 117490599958, 117490599959, 117500601066, 117480597585, 117490599960, 117510602015, 117510602783, 118010604423, 118030607407, 118030607409, 118050609952, 118090615612, 118090616239, 118190635182, 118180633951, 118150626794, 118110620676, 118110620675, 118030607408, 118110620673, 118110620672, 118110620671, 118110620670, 118120622027, 118110620674, 116520545400, 116520545401, 118200637266, 118200637265, 118200637264, 118190635507, 118190635506, 118190635505, 118190636600, 118190636599, 118210638582, 118210638581, 118240001206, 118250002189, 118250002190, 118260000335, 118260000336, 118260000337, 118260000338, 118260000339, 118260000340, 118260000341, 118260000342, 118260000343, 118270000716, 118270000717, 118300001211, 118300001212, 118310000439, 118310000440, 118310001698, 118340000909, 118340000910, 118340000911, 118350000119, 118350000120, 118350000895, 118360000412, 118370000771, 118370000772, 118370001923, 118390000401, 118400000212, 118400000213, 118420000444, 118420000445, 118450000914, 118450000915, 118460002307, 118480000811, 118480000812, 118480000813, 118490000215, 118490000216, 118520000469, 119030000098, 119060000834, 119070000043, 119090001179, 119100000457, 119120000287, 119120001590, 119120001591, 119160000320, 119190000655, 119220000831, 119230002432, 119230002433, 119240000162, 119240000163, 119240000739, 119250000556, 119250000557, 119250000558, 119260000972, 119260000973, 119260000974, 119260000975, 119260000976, 119260000977, 119260001787, 119260001788, 119260001789, 119270000453, 119280000608, 119280000609, 119290000534, 119290000601, 119300000175, 119330000158, 119330000159, 119330000810, 119350002908, 119350002909, 119380001374, 116300519874, 116300519875, 116300519876, 119420001080, 119420001081, 119420001082, 119420001083, 119460000136, 119460000137, 119460000138, 119460001074, 119460001075, 119470000521, 119470000522, 119470001904, 119470001905, 119470001906, 119470001907, 119480000259, 119480000260, 180, 119500001102, 119500001103, 119500001104, 119520000619, 119520000620, 120020001162, 120050000516, 120060000648, 120070001212, 120070001213, 120070001214, 120070001215, 120070001216, 120070001217, 120080002241, 120080002242, 120110001828, 120110001829, 120110001830, 120130000348, 120130000349, 120130001386, 120130001387, 120140001041, 120140001042, 120140001043, 120140002514, 120140002515, 120160001500, 120160001501, 120160001502, 120160001503, 120160001504, 120160001505, 120180001098, 120180001099, 120180001100, 120180001101, 150160001505, 120230002008, 120230002009, 120230002010, 120230002011, 120230002012, 120230002013, 150160001506, 150160001507, 150160001508, 150160001509, 150160001510, 150160001511, 120310001596, 120310001597, 120310001598, 120360001242, 120360001243, 120360001244, 120360001245, 120380000309, 120380000310, 120390000394, 120390001597, 120390001598, 120400001334, 120400001335, 120410000592, 120410001054, 120410001292, 120410001293, 120410001294, 120410001295, 120410001296, 120450000602, 150160001513, 150160001514, 150160001515, 150160001516, 150160001517, 120460000684, 120460000685, 120460000686, 120460002793, 120460002794, 120470000599, 120480000005, 120480000006, 120480000007, 120490001517, 120490001518, 120490001519, 120490001520, 120490001521, 120490001522, 120490001523, 120490001524, 120490003111, 150160001518, 150160001519, 150160001520, 150160001521, 150160001522, 150160001523, 150160001524, 150160001525, 150160001526, 150160001527, 150160001528, 150160001529, 150160001530, 150160001531, 121030000755, 121030000756, 121070000464, 121070002513, 121070002514, 121090001937, 121090001938, 121090001939, 121090001940, 121120000018, 121120000019, 121120000020, 121120000021, 121120000022, EXCNORETURN, 121140000280, 121140000281, 121140000282, 121160001418, 121160001419, 121190000939, 121200000017, 121200000018, 121230000160, 121230000161, 121230002023, 121240000675, 121240000676, 121240000677, 121300001874, 121310001142, 12130001679, 121330001320, 150160001532, 121360001298, 121360001299, 121360001300, 121360001301, 121360001302, 121390002096, 121390002097, 121390002098, 121400000055, 121400001921, 121400001922, 121400001923, 121420000476, 121430000259, 121450000280, 121450001401, 121460001164, 121480000753, 121480000754, 121500000287, 121500000288, 121500000289, 121500000290, 121500000291, 121500000292, 121510001474, 121510001475, 121520000976, 121520000977, 121520000978, 121520000979, 121520000980, 121520000981, 121520001607, 121520001608, 122010001005, 122010001006, 122010001007, 122010001008, 122020000513, 122020001900, 122020001901, 122020001902, 122020001903, 122040000642, 122040000643, 122050001244, 122050001245, 122050001246, 122050001247, 122070001238, 122070001239, 122070001240, 122070001241, 122070001242, 122250000648, 122250000649, 122250000650, 122250000651, 122250000652, 122250000653, 122250000654, 122250000655, 122250000656, 122260000886, 122290001134, 122290001135, 122290001136, 122290001137, 122290001138, 122310001545, 122310001546, 122320000462, 122350000276, 122350000277, 122360000423, 122360000424, 122370000068, 122370000069, 122370000070, 122430000183, 122450000618, 122450000619, 8, 122480002103, 122480002104, 122480002105, 122480002106, 122490000194, 122490000195, 122490000196, 122490000197, 122490000198, 122490000199, 122500001002, 122500001003, 122500001004, 122510000167, 123010000259, 123010000260, 123010000261, 123010000262, 123010000263, 123030001333, 123030001334, 123030001335, 123050001345, 123050001346, 123050001347, 123050001348, 123070000719, 123090001294, 123100001960, 123100001961, 123100001962, 123100001963, 123100001964, 123170000267, 123180000488, 123180000489, 123210000350, 123210000351, 123250000059, 123250000060, 123250000061, 123250000062, 123250000063, 123250000064, 123250001027, 123260000226, 123270000161, 123270001064, 123270001065, 123270001066, 123270001067, 123270001068, 123270001069, 123270001070, 123270001071, 123280000373, 123280000374, 123280000375, 123290000582, 123290000583, 123290000584, 123300001832, 123300001833, 123300001834, 123310001376, 123310001377, 123310001378, 123330000777, 123330000778, 123330000779, 123350000286, 123350000287, 123350000288, 123350000289, 123380001337, 123380001338, 123410000814, 123410000815, 123430001155, 123430001156, 123430001157, 123430001158, 123430001159, 123430001160, 123430001161, 123430001162; rr) QS-6AA-XCAAA, UDI/DI 00732094326710, Serial Numbers: 122120000190, 122100001656, 122090001811, 122090001810, 122020001000, 122020000999, 122020000998, 121520000975, 121160002375, 120170000553, 120170000554, 122300000629; ss) QS6-MLTCX, UDI/DI 0081234502764821, Serial Numbers: 116080321499, 116100346607, 116130375989, 116130375990, 116130379805, 116210439189, 116210438778, 116230453065, 116230453067, 116250485173, 116240477775, 116260493401, 116240459074, 116270501516, 116270498867, 116280505345, 116290517124, 116290519660, 116300520391, 116320522163, 116320522164, 116320522165, 116330522667, 116330523071, 116340523724, 116350524070, 116380527757, 116410531127, 116480540910, 116490541437, 116490541641, 116520545376, 116530547261, 117030551128, 117040552523, 117050552696, 117110556421, 117110556410, 117140561569, 117170564846, 117160563413, 117170566130, 117180566599, 117190568194, 117190568195, 117210569780, 117210569781, 117230572912, 117250574779, 117260576265, 117260576266, 117280577952, 117270577275, 117300580503, 117330583101, 117370586229, 117370585824, 117390587807, 117470596277, 117470596278, 117510602013, 117510602014, 118020605911, 118030607257, 118030607726, 118070613217, 118100617591, 118180634595, 118180634594, 118150627077, 118150627076, 118160628070, 118140625630, 118120622030, 118130624174, 118110620680, 118110620681, 118190636335, 118190635558, 118250001741, 118270000718, 118270000719, 118270000720, 118270000721, 118270000722, 118290000378, 118290000379, 118290000380, 118290001179, 118310000441, 118310001116, 118350000122, 118350000590, 118370000778, 118370000779, 118390000402, 118410000880, 118420000601, 118420000602, 118420000603, 118430000952, 118430000953, 118440001585, 118490000218, 118500000650, 118500002165, 118500002166, 118520000908, 118520000909, 118520000910, 119040000855, 119050000688, 119050000689, 119070000660, 119070000661, 119100001181, 119120000288, 119120001592, 119120001593, 119200000582, 119220000667, 119250000564, 119250000565, 119250000566, 119250000567, 119250000568, 119250000569, 119270000450, 119270000451, 119270000452, 119280000613, 119320000060, 119330000161, 119340000677, 119340000678, 119350002913, 119350002914, 119350002915, 119350002916, 119350002917, 119350002918, 119350002919, 119350003338, 119350003339, 119370000198, 119370000199, 119370000200, 119370000201, 119370001057, 119370001058, 119400001644, 119400001645, 119400001646, 119400001647, 119400001648, 119400001649, 119400001650, 119400001651, 119460001807, 119460001808, 119480000257, 119480000258, 119510000666, 119510001674, 119520000618, 120020001161, 120080000361, 120130000350, 120130000351, 120140001044, 120180000985, 120180000986, 120330000901, 120330000902, 120330000903, 120390000399, 120430001822, 120450001901, 120470000596, 120530000380, 120530000381, 120530000382, 120530000383, 120530000384, 120530000385, 121040002695, 121060000885, 121060000886, 121070000470, 121070000471, 121070000472, 121070000473, 121070001276, 121070001277, 121080000530, 121090001941, 121090001942, 121130001102, 121130001103, 121140000283, 121140000284, 121140000285, 121160002372, 121160002373, 121160002374, 121190000640, 121200000019, 121200000020, 121200000021, 121200000022, 121200001237, 121200001238, 121200001239, 121220000152, 121220000153, 121220000154, 121220000163, 121230000162, 121240001241, 121290001061, 121290001062, 121300001865, 121300001877, 121310001017, 121350000322, 121350000323, 121350000324, 121350001471, 121360001294, 121360001295, 121370000469, 121370001278, 121370001279, 121390000796, 121430000260, 121450000287, 121450001402, 121450001403, 121480001495, 121520000984, 121520001599, 121520001600, 122010000983, 122020001212, 122020001213, 122020001214, 122020001215, 122040000385, 122050001248, 122050001249, 122060002362, 122060002363, 122090001804, 122090001805, 122110000027, 122120002575, 122120002576, 122120002577, 122140000068, 122190001152, 122190001153, 122190001154, 122190001155, 122190001156, 122190001157, 122190001158, 122190001159, 122190001160, 122190001161, 122230000221, 122240001156, 122240001157, 122240001158, 122240001491, 122290001139, 122340000213, 122380000699, 122390000780, 122410001720, 122430001370, 123010001027, 123010001028, 123010001029, 123030000270, 123040001234, 123040001235, 123040001929, 123070000717, 123070000718, 123080000641, 123080000642, 123110001327, 123190001330, 123230001869, 123280000406, 123280001081, 123300001828, 123300001829, 123300001830, 123320000984, 123350000290, 123430001163, 123430001164; tt) QS6-MTTCX, UDI/DI 0081234502766221, Serial Numbers: 116130382738, 116140389728, 116150390531, 116200435411, 116220448959, 116250480265, 116300520110, 116300520111, 116300520112, 116300520113, 116360525386, 116360525794, 116370526230, 116380528390, 116380528391, 116380527756, 116420532146, 116460538198, 116460538356, 116530546826, 116530546811, 116530546820, 116530546821, 116530546822, 116530546823, 116530546824, 116530546825, 117010548789, 117010548790, 117020550495, 117050553051, 117080555509, 117110556504, 117130560261, 117130560971.117130560972, 117130560973, 117130560974, 117140562016, 117140562066, 117190567380, 117200568648, 117250574073, 117250574074, 117370585092, 117370585113, 117370585090, 117370585091, 117370585093, 117370585094, 117370585110, 117370585111, 117370585112, 117420590606, 117430591572, 117470596276, 117500601524, 117500601525, 117500601526, 117500601527, 118030607881, 117520603557, 117520603558, 117520603559, 117520603560, 117520603561, 118070612283, 118040607881, 118180634593, 118120622400, 118120622028, 118110620684, 118270000723, 118290000381, 118360000418, 118500002168, 119050000693, 119090000899, 119170000012, 119200000994, 119450000817, 120190000899, 120240000419, 120480001167, 121030000256, 121030000257, 121040002691, 121040002692, 121040002693, 121040002694, 121060000878, 121060000879, 121060000880, 121060000881, 121060000882, 121060000883, 121060000884, 121060000919, 121070002432, 121190000641, 121190000642, 121300001282, 121340000509, 121340000510, 121350001470, 121370002509, 121510001478, 121510001479, 121510001480, 121510001481, 122020000732; uu) QS-6AA-CDCAA, UDI/DI 00732094286021, Serial Numbers: 118180633960; vv) QS-6AA-DDCAA, UDI/DI 00817655021355, Serial Numbers: 117140561568; ww) QS-6BC-CGAAA, UDI/DI 00732094263589, Serial Numbers: 116190425280; xx) QS-6BC-CDCXA, UDI/DI 00732094263596, Serial Numbers: 116140389770; yy) QS-6BB-CFAAB, UDI/DI 00732094263626, Serial Numbers: 116170410170; zz) QS6-ATTD1, UDI/DI 0081234502756321, Serial Numbers: 116070311290, 116070311292, 116070311294, 116100332892, 116130382051, 116130376108, 116140389082, 116140388756, 116170410169, 116180416553, 116180416555, 116190431282, 116210444330, 116230450214, 116230450216, 116240477304, 116240477860, 116240477862, 116240477864, 116240477867, 116240477869, 116240477871, 116230455570, 116230455572, 116230455574, 116230455576, 116230455578, 116230455580, 116230455582, 116230455584, 116230455588, 116310520897, 116310520898, 116230455586, 116310520896, 116320521690, 116320521865, 116330522902, 116330522848, 116330522849, 116340523648, 116350524130, 116370526975, 116400529514, 116400529515, 116400529516, 116400529517, 116400529518, 116390529090, 116370526974, 116400529519, 116400529520, 116400529521, 116400529522, 116400529523, 116400529920, 116400529921, 116400530088, 116400530553, 116400530028, 116420531722, 116420532142, 116430534054, 116430534055, 116450536077, 116450536208, 116460537576, 116460538355, 116460537453, 116470539394, 116490542247, 116490542248, 116510544247, 116510545330, 116510545331, 116520546402, 116520546401, 116520546230, 116520546403, 116520546400, 117050553073, 117060553950, 117080555092, 117090555749, 117090555843, 117090555865, 117090555866, 117090555867, 117110556362, 117110556363, 117110556289, 117110556290, 117120556937, 117120557454, 117120557458, 117120557459, 117120557460, 117130560125, 117130560428, 117130560970, 117140562012, 117150562725, 117140562010, 117140562011, 117150562893, 117160564733, 117170565765, 118210000029, 118210000030, 117200568387, 117200568404, 117190568245, 117190568246, 117190568247, 117190568248, 117190568249, 117200568664, 117200568665, 117200568666, 117210570494, 117220571853, 117220571854, 117220571855, 117220571856, 117240573477, 117250575043, 117250574851, 117260576250, 117290578774, 117290579353, 117300579812, 117300579810, 117320581838, 117310581538, 117330582979, 117350583853, 117350583854, 117340583699, 117350583855, 117340583702, 117350584009, 117350584025, 117350584041, 117350584042, 117350584043, 117360584752, 117360585080, 117370585583, 117380586304, 117380586303, 117380587697, 117380587478, 117380587698, 117410589631, 117400589312, 117410589632, 117410589633, 117430591573, 117440593332, 117440593333, 117440593334, 117440593335, 117440593336, 117440593337, 117430592467, 117430592468, 117470596323, 117470596320, 117470596321, 117470596322, 117470596324, 117470596325, 117490599956, 117490599050, 117480597582, 117500600631, 117500600630, 117500600632, 117500600633, 117520603148, 117510602771, 117520603149, 118010605331, 118030607571, 118030607572, 118030607406, 118050609192, 118050609228, 118060610911, 118060610912, 118070613219, 118090615613, 118090615614, 118090615615, 118100617471, 118100617472, 118110618490, 118180634182, 118150627494, 118150627493, 118150627068, 118160628174, 118140626434, 118140626433, 118130624868, 118120622403, 118120622402, 118120622026, 118180634181, 118180635054, 118180635051, 118180635050, 118180634183, 118180635052, 118180635053, 118240001668, 118240001669, 118240001831, 118240001832, 118240001833, 118250001326, 118250001327, 118260000781, 118260000782, 118270000714, 118270000715, 118280001257, 118280001258, 118280001259, 118280001260, 118280001261, 118290000376, 118290000377, 118290000867, 118290001241, 118290001242, 118290001243, 118320001185, 118340000905, 118340000906, 118340000907, 118340000908, 118350000117, 118350000118, 118360000051, 118360000052, 118360000053, 118360000054, 118360000055, 118360000056, 118360000057, 118360000058, 118360000059, 118360000518, 118360000519, 118360000520, 118360000521, 118360000522, 118360000523, 118360000524, 118360000525, 118380001931, 118380001932, 118390000386, 118390000387, 118390000388, 118390000389, 118390000390, 118400000207, 118400000208, 118400000209, 118400000210, 118400000211, 118400000698, 118400000699, 118400000700, 118430001304, 118430001305, 118430001306, 118450001177, 118460001582, 118460001583, 118470000260, 118470000261, 118500000639, 118500000640, 118500000641, 118500000642, 118500000643, 118520000905, 119040000854, 119050000681, 119050000682, 119050000683, 119050000684, 119060001359, 119060001360, 119070000214, 119070000215, 119070000216, 119080000186, 119080000187, 119080000188, 119080000189, 119110000756, 119120001149, 119120001150, 119120001151, 119120001152, 119160000318, 119160000319, 119170000425, 119200001274, 119200001822, 119210001020, 119210001021, 119220000664, 119220000665, 119220001048, 119220001049, 119230002429, 119230002430, 119230002431, 119250000553, 119250001410, 119250001411, 119250001414, 119250001415, 119260000126, 119260000127, 119280001372, 119280001749, 119280001750, 119310000245, 119310000246, 119310000247, 119310000248, 119310001358, 119310001359, 119310001360, 119330000157, 119330000808, 119330000809, 119380001356, 119380001357, 119380001358, 119380001359, 119380001360, 119380001361, 119380001362, 119380001363, 119380001364, 119380001365, 119380001366, 119390001988, 119390001989, 119390001990, 119390000615, 119400000248, 119400000249, 119400000250, 119400000254, 119400000255, 119400001290, 119400001291, 119400001292, 119400001293, 119400001294, 119400001295, 119430001817, 119430001818, 119430001819, 119430001820, 119430001821, 119430001822, 119430001823, 119450001900, 119450001901, 119450001902, 119450001903, 119450001904, 119450001905, 119450001906, 119460001072, 119460001073, 119490000495, 119490000496, 119490000497, 119490000498, 119490000499, 119490000500, 119500000110, 119500000529, 119500000530, 119500000531, 119500000532, 119500000533, 119500001528, 119500001529, 119500001530, 119500001531, 119500001532, 119510000661, 119510000662, 119510000663, 119510000664, 119510000665, 119510001185, 119510001186, 119510001187, 119510001188, 119510001189, 119520000621, 119520000622, 119520000623, 120010000754, 120010000755, 120020001163, 120030000546, 120040000641, 120040000642, 120040000643, 120050000441, 120050000442, 120050000443, 120060000937, 120070001199, 120070001200, 120080000836, 120090001324, 120090001325, 120090001326, 120090001327, 120100000623, 120100000624, 120100000625, 120100000626, 120100001903, 120100001904, 120100001905, 120100001906, 120100001907, 120100001908, 120110002511, 120120000635, 120120000636, 120120000637, 120120000638, 120120001441, 120120001442, 120120001443, 120130000345, 120130000346, 120130000347, 120130001075, 120130001076, 120130001077, 120130001078, 120150002418, 120150002419, 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123140000705, 123140000706, 123140000707, 123140000750, 123140000751, 123140000752, 123140000753, 123140000754, 123140001384, 123140001385, 123140001386, 123140001387, 123150001149, 123150001150, 123230000930, 123230000931, 123230000932, 123230000933, 123230000934, 123240001033, 123240001034, 123240001035, 123240001036, 123240001037, 123250000709, 123250000710, 123250000711, 123250000712, 123250000713, 123250000788, 123250000789, 123250000790, 123250000791, 123250000792, 1231400001384, 1231400001385, 123270000268, 123270000269, 123270000270, 123270000271, 123270000272, 123270000273, 123270000274, 123270000275, 123270000276, 123270000277, 123270000278, 123280000407, 123280000408, 123280000409, 123290000577, 123290000578, 123290000579, 123300001483, 123300001484, 123300001485, 123310000824, 123310000825, 123310001371, 123310001372, 123310001373, 123330000139, 123330000140, 123380001327, 123380001328, 123380001329, 123380001330, 123380001331, 123380001332, 123380001333, 123410000813; aaa) QS-6BA-ACAAB, UDI/DI 00732094263671, Serial Numbers: 120050000514; bbb) QS-6BD-ACAAB, UDI/DI 00812345027594, Serial Numbers: 122490001735, 122440000911, 122370001543, 122260001675, 122260001674, 122040000384, 121400000047, 121370000468, 121330001324, 121330001323, 121330001322, 121330001321, 121140001536, 121120000015, 121090000179, 121090000178, 121090000177, 121090000176, 121070001281, 120400002608, 120400002607, 120400002606, 120400002605, 120400000342, 120400000341, 120400000340, 120400000339, 120400000338, 120400000337, 120400000336, 120400000335, 120400000334, 120330000290, 120320000363, 120320000362, 120220001020, 120220001019, 120120001447, 120120001446, 120120001445, 120120001444, 120120000639, 120110000199, 120110000198, 120110000197, 120110000196, 120110000195, 120100000629, 120100000628, 120100000627, 120090001349, 120090001348, 120090001347, 120050000645, 120050000644, 120050000643, 120050000642, 120050000641, 120050000640, 120050000579, 120050000578, 120050000577, 120050000576, 120050000575, 120050000574, 119470001911, 119470001910, 119470001909, 119470001908, 119390000710, 119390000709, 119390000708, 119390000707, 119390000706, 118380001939, 118380001938, 118380001937, 118380001936, 118380001935, 118380001934, 118380001933, 118350000589, 118350000588, 118330000152, 117510602786, 117320582072, 117250574850, 117250574849, 117200568393, 117200568392, 116240457675, 116210442891, 116210442889, 116210442887, 116210442885, 116200436401, 116200436399, 116200436397, 116200436395, 116130383210; ccc) QS-6BA-ACAAA, UDI/DI 00732094263688, Serial Numbers: 116400530718, 116400530717, 116400530716, 116400530715, 116180416249; ddd) QS-6BA-ACBAA, UDI/DI 00732094263664, Serial Numbers: 115280263474, 115280263473, 115280263472; eee) QS-6BA-DDDAA, UDI/DI 00732094263640, Serial Numbers: 115330268505; fff) QS6-MLTC1, UDI/DI 0081234502763121, Serial Numbers: 116060303443, 116070305534, 116070305533, 116070308880, 116090332688, 116090332690, 116090330913, 116090330915, 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118380001946, 118380001947, 118380001948, 8004779682, 118400000215, 118400000216, 118400000217, 118400000702, 118400000703, 118400000704, 118400000705, 118400000706, 118400000707, 118400000708, 118400000709, 118400000710, 118400000711, 118400000712, 118410000878, 118410000879, 118420000138, 118420000139, 118420000140, 118420000141, 118420000142, 118420000143, 118420000144, 118440000155, 118440000156, 118440000157, 118440000158, 118440000568, 118440000569, 118440000570, 118450000996, 118460001581, 118460002310, 118460002311, 118470000262, 118480000499, 118480000819, 118500000644, 118500000645, 118500000646, 118500000647, 118500000648, 118500000649, 118500002164, 118520000407, 118520000408, 118520000409, 118520000906, 118520000907, 119020000210, 119020000211, 119020000212, 119020001263, 119040000051, 119040000052, 119050000686, 119050000687, 119060000835, 119060000836, 119060000837, 119070000044, 119070000045, 119070000046, 119070000047, 119070000658, 119070000659, 119080000190, 119080000191, 119080000969, 119080000970, 119080000971, 119080000972, 119080000973, 119080000974, 118360000418, 119120001146, 119120001147, 119120001148, 119140000924, 119140001248, 119140001249, 119150000794, 119150000795, 119150000796, 119150000797, 119170000011, 119170000427, 119170000578, 119170000579, 119180000992, 119180000993, 119180000994, 119190000656, 119200000236, 119200000237, 119200000238, 119200001275, 119200001276, 119210001022, 119210001023, 119210001024, 119220000666, 119230003593, 119230003594, 119230003595, 119250000560, 119250000561, 119250000562, 119250000563, 119260000124, 119260000125, 119280000610, 119280000611, 119280000612, 119280001370, 119280001371, 119280001747, 119280001748, 119290000344, 119290000345, 119310001731, 119310001732, 119310001733, 119310001734, 119330000160, 119330000637, 119330000638, 119330000639, 119330000640, 119330000825, 119330000826, 119330000827, 119330000828, 119330000829, 119320001020, 119260000367, 119350000637, 119350002911, 119350002912, 119370000194, 119370000195, 119370000196, 119370000197, 119370001377, 119370001378, 119370001379, 119370001380, 119370001381, 119370001382, 119370001383, 119370001384, 119380001369, 119380001370, 119380001371, 119380001372, 119380001373, 119400000251, 119400000252, 119400000253, 119400000256, 119400000257, 119400000258, 119420001135, 119430000051, 119430000052, 119430000053, 119430000054, 119430000055, 119430000056, 119430000057, 119430000058, 119440000808, 119440000809, 119440000810, 119440000811, 119440000812, 119470002282, 119470002283, 119470002284, 119470002285, 119470002286, 119470002287, 119490000501, 119490000502, 119490000503, 119490000504, 119490000505, 119500000160, 119500000161, 119500000162, 119500000163, 119500000534, 119500000535, 119500000536, 119500000537, 119500000538, 119500000539, 119510001200, 119510001201, 119520000625, 119520000626, 119520000627, 120010000567, 120010000568, 120020000871, 120020000872, 120040000932, 120040000933, 120090001350, 120090001351, 120090001352, 120090001353, 120100000534, 120100000535, 120100000536, 120100000619, 120100000620, 120100000621, 120100000622, 120100001918, 120100001919, 120120000646, 120120000647, 120120000648, 120120001448, 120120001449, 120130001079, 120130001080, 120160001494, 120160001495, 120160001496, 120160001497, 120160001498, 120160001499, 120170001337, 120170001338, 120170001339, 120170001340, 120170001341, 120170001342, 120170001344, 120190002006, 120200001396, 120210001720, 120210001721, 120210001722, 120220000395, 120230000479, 120230002020, 120230002021, 120230002022, 120230002023, 120230002024, 120230002025, 120230002026, 120230002027, 120230002028, 120230002029, 120280000132, 120280000899, 120290000982, 120290000983, 120300000080, 120300001281, 120300001282, 120310000859, 120310000860, 120310000861, 120310000862, 120310000863, 120310000864, 120320000357, 120320000358, 120330000510, 120330000511, 120330000512, 120330000513, 120330000514, 120340000249, 120340000250, 120340000251, 120350000751, 120360000452, 120360000453, 120360000454, 120360000455, 120360000456, 120360001048, 120360001049, 120370001244, 120370001245, 120380001113, 120380001114, 120390000396, 120390000397, 120390000398, 120390001749, 120390001750, 120400000343, 120400000344, 120410000593, 120410000594, 120410000595, 120430000335, 120430000336, 120430000337, 120430000338, 120430000828, 120430000829, 120430000830, 120430000831, 120440000911, 120450001799, 120450001800, 120460002154, 120460002155, 120470000595, 120490000203, 120490000204, 120490000205, 120490000206, 120490002759, 120490002760, 120510000295, 120510000296, 120510000297, 120510000298, 120510000299, 120290000206, 121050001919, 121050001920, 121060000920, 121060000921, 121060000922, 121060000923, 121060000957, 121060000958, 121060000959, 121070000466, 121070000467, 121070000468, 121070000469, 121070001282, 121070001283, 121070001284, 121070001285, 121070001286, 121080000967, 121080000968, 121080000969, 121080000970, 121080002710, 121080002711, 121100001502, 121100001503, 121110000820, 121110000821, 121110000822, 121110000823, 121120000869, 121120000870, 121120000871, 121120000872, 121120000873, 121130001096, 121130001097, 121130001098, 121130001099, 121130001100, 121130001101, 121140000286, 121140000287, 121140000288, 121150000198, 121150000199, 121150000200, 121160000934, 121160000935, 121160002367, 121160002368, 121160002369, 121160002370, 121160002371, 121180000759, 121180000760, 121190000161, 121190000162, 121190000163, 121190000164, 121190000940, 121190000941, 121190000942, 121190000943, 121190000944, 121200002302, 121200002303, 121200002304, 121200002305, 121200002306, 121200002307, 121200002308, 121200002309, 121210002568, 121210002569, 121210002570, 121210002571, 121210002572, 121210002573, 121230002024, 121240001239, 121240001240, 121290001067, 121290001068, 121300001866, 121300001867, 121300001868, 121300001869, 121310001012, 121310001013, 121310001014, 121310001015, 121310001016, 121320000691, 121320000692, 121320000693, 121340000511, 121340000512, 121350000318, 121350000319, 121350000320, 121350000321, 121350001467, 121350001468, 121350001469, 121360000905, 121360000906, 121360000907, 121360000908, 121360000909, 121360001296, 121360001297, 121370001271, 121370001272, 121370001273, 121370001274, 121370001275, 121370001276, 121370001277, 121380000286, 121380000287, 121380000288, 121380001678, 121380001679, 121380001680, 121380001681, 121400000052, 121400000053, 121400000054, 121410000502, 121410000503, 121410002030, 121410002031, 121410002032, 121410002033, 121420000477, 121420000478, 121420000479, 121420000480, 121420000481, 121440000131, 121440000132, 121440000133, 121440000134, 121450000281, 121450000282, 121450000283, 121450000284, 121450000285, 121450000286, 121440000126, 121470000321, 121470000322, 121470000323, 121470000324, 121470000325, 121440000128, 121470001238, 121470001239, 121470001240, 121470001241, 121470001242, 121470001243, 121480000755, 121480000756, 121480000757, 121480000758, 121480000759, 121490000358, 121490000359, 121490000360, 121490000361, 121490000812, 121490000813, 121510000634, 121510000635, 121520000982, 121520000983, 122010000990, 122010000991, 122020001904, 122020001905, 122020001906, 122020001907, 122020001908, 122020001909, 122050000152, 122050000153, 122050000154, 122050000155, 122060000615, 122080000275, 122090000844, 122100000097, 122100000098, 122100001649, 122100001650, 122100001651, 122120002578, 122120002579, 122120002580, 122120002581, 122120002582, 122150000895, 122150000896, 122150000897, 122150000898, 122150000899, 122150000900, 122160000388, 122180001859, 122180001860, 122180001861, 122200001815, 122200001816, 122200001817, 122200001818, 122220000688, 122220000689, 122220000690, 122220000691, 122220000692, 122230000222, 122230000223, 122230000224, 122230000225, 122230000226, 122240001486, 122240001487, 122240001488, 122240001489, 122240001490, 122270001030, 122270001031, 122270001032, 122270001033, 122320000179, 122320000180, 122320000181, 122320000182, 122330000528, 122330000529, 122330000530, 122330000531, 122350000761, 122350000762, 122360000831, 122360000832, 122360001384, 122360001385, 122360001386, 122370001103, 122370001104, 122370001105, 122370001106, 122380002041, 122380002042, 122380002043, 122380002044, 122380002045, 122400000635, 122400000636, 122400000637, 122410001219, 122410001220, 122430000176, 122430000177, 122430000178, 122430000179, 122440000143, 122440000144, 122440000145, 122440000146, 122450002107, 122450002108, 122450002109, 122450002110, 10081234502763100, 122490000181, 122490000182, 122490000183, 122490000184, 122490000185, 122500000992, 122500000993, 122500000994, 122500000995, 122500000996, 122500000997, 122510000162, 122510000163, 122510000164, 122510000165, 122510000166, 123010000264, 123010000265, 123010000266, 123010000267, 123010000268, 123030001326, 123030001327, 123030001328, 123040001808, 123040001809, 123040001810, 123040001811, 123040001812, 123060000571, 123060000572, 123060000573, 123080000133, 123080000134, 123080000135, 123100001965, 123100001966, 123100001967, 123110000413, 123110000414, 123110000415, 123110001827, 123120000946, 123130000024, 123130000025, 123130000026, 123140000916, 123140000917, 123140000918, 123250000783, 123250000784, 123250000785, 123250000786, 123250000787, 123250000797, 123250000798, 123250000799, 123250000800, 123250000801, 123, 10081234502756300, 123270000818, 123270000819, 123270000820, 123270000821, 123270000822, 123270000823, 123290000465, 123290000466, 10081765502315100, 123290000580, 123290000581, 123310001374, 123310001375, 123320000690, 123320000691, 123320000692, 123330000141, 123330000142, 123380001334, 123380001335, 123380001336; ggg) QS6-MTTC1, UDI/DI 0081234502765521, Serial Numbers: 116110348789, 116110348788, 116120372878, 116130381404, 116150390530, 116180422818, 116180422819, 116190431238, 116200431775, 116220445030, 116230455473, 116240476428, 116240476430, 116260491976, 116260492396, 116260492282, 116270496479, 116270500137, 116290511521, 116300520154, 116330522723, 116360525811, 116370526594, 116370526595, 116370526596, 116370526973, 116380528392, 116380528393, 116390529242, 116400529524, 116400529617, 116420531849, 116430534052, 116430534165, 116430534166, 116430534164, 116440535723, 116470539298, 116480540046, 116480540057, 116470539685, 116470539686, 116480540330, 116500542872, 116520545871, 1164005296172, 117020550455, 117030550920, 117040552027, 117050552694, 117060553846, 117060553951, 117050553048, 117080554690, 117120557457, 117120558329, 117130560357, 117150562925, 117160563887, 117180567012, 117210570355, 117230572019, 117240573533, 117260576906, 117260576915, 117270577089, 117280578275, 117290578968, 117290578967, 117320582106, 117340583182, 117350583859, 117350584568, 117350584733, 117370585584, 117380587440, 117390588204, 117390588205, 117400589301, 117400589302, 117420591113, 117470596275, 117480596711, 117480596713, 117480596712, 118030606920, 118030607575, 118050609227, 118070612349, 118090616238, 118180632919, 118130624384, 118120622031, 118180634185, 118230000263, 118230000264, 118230000265, 118180634184, 118240001674, 118240001834, 118260000334, 118270000043, 118290001246, 118320001193, 118340000919, 118340000920, 118340000921, 118340000922, 118350001198, 118350001199, 118350001200, 1183500011200, 118380001949, 118400000713, 118400000714, 118400000715, 118420000145, 118420000146, 118420000446, 118420000447, 118440000159, 118500000651, 118500002167, 118520000911, 118520000912, 119050000690, 119050000691, 119050000692, 119070000662, 119070000663, 119100001582, 119100001583, 119120000289, 119130000115, 119140000663, 119170000580, 119200001277, 119250000570, 119250000571, 119250000572, 119260001672, 119320001020, 119380001367, 119380001368, 119390000721, 119390000722, 119400000269, 119400000270, 119400000271, 119400000272, 119460000140, 119490000254, 119510000667, 119510000668, 119510000669, 120020001164, 120200000542, 120240002425, 120270000025, 120310001430, 120360001050, 120410000596, 120480001166, 120510000547, 120510000548, 120510000549, 120510000550, 120510000551, 120510003264, 120510003265, 120510003266, 121040003181, 121040003182, 121040003183, 121040003184, 121040003185, 121040003186, 121040003187, 121070001278, 121070001279, 121080000971, 121080000972, 121080000973, 121120000016, 121120000017, 121120000875, 121120000876, 121140001780, 121170001236, 121170001237, 121190000165, 121190000166, 121190000167, 121240001235, 121240001236, 121290001073, 121290001074, 121290001075, 121300001875, 121300001876, 121320000688, 121320000689, 121320000690, 121340000885, 121340000886, 121360001286, 121370002503, 121370002504, 121370002505, 121370002506, 121370002507, 121390002094, 121390002095, 121400000056, 121400001924, 121480000760, 121510000636, 122110001201, 122110001478, 123090000683; hhh) QS-6CC-XXAXA, UDI/DI 00732094313819, Serial Numbers: 122320000460, 122320000459, 122320000458, 121290001066, 121290001065, 119390002174, 119210001603, 119100000463; iii) QS-6CC-XXBXX, UDI/DI 00732094263466, Serial Numbers: 122240001154, 122240001153, 122240001152, 119340000875, 119090000533, 119090000532, 119090000531, 119090000530, 119090000529, 119090000528, 119090000527, 119090000526, 119090000525, 119090000524, 118100617943, 118100617942, 118100617941, 118100617940, 118100617939, 117520603270; jjj) QS-6CC-XGAAB, UDI/DI 00732094323726, Serial Numbers: 119320000899; kkk) QS-6CC-DGCAX, UDI/DI 00732094263480, Serial Numbers: 117200569698; lll) QS-6CC-XAAXX, UDI/DI 00732094324075, Serial Numbers: 122410000835; mmm) QS-6CC-DFCAX, UDI/DI 00732094263497, Serial Numbers: 118480000814, 118260000783, 117090555981; nnn) QS-6CA-DGCAA, UDI/DI 00732094263558, Serial Numbers: 117300580772; ooo) QS-6CB-CXCXA, UDI/DI 00732094263534, Serial Numbers: 116250485458, 116250485456, 116250485452, 116250485450, 116190431292, 116190431290, 116190431288; ppp) QS-6CB-DFCAX, UDI/DI 00732094263527, Serial Numbers: 116130375991; qqq) QS-6CA-DFCAA, UDI/DI 00732094263565, Serial Numbers: 117300580771; rrr) QS-6XC-XXXXA, UDI/DI 00732094308457, Serial Numbers: 123330000866, 123330000867, 123330000868, 123330000869, 123330000870, 123330000871; sss) QS-6XC-BXXXX, UDI/DI 00732094263183, Serial Numbers: 116460538337; ttt) QS-6XC-XXXXB, UDI/DI 00732094321029, Serial Numbers: 119260000098; uuu) QS-6XA-DFXAA, UDI/DI 00732094263190, Serial Numbers: 117200569697; vvv) QS6-STTDX, UDI/DI 00732094336054, Serial Numbers: 120210000789, 120210000791, 120210000792, 120210000795, 120210000797, 120210000798, 120210000799, 120210000800, 120210000801, 120210000802, 120210000805, 120210000807, 120210000808, 120210000810, 120210000813, 120210000815, 120210000816, 120210000819, 120210000820, 121400000901, 121400000902, 122190000640, 122190000641, 122350000278, 122350000279, 123170000266, 123260000923, 123260000924; www) QS6-STTD1, UDI/DI 00732094336061, Serial Numbers: 120210000797, 120210000798, 120210000792, 120210000791, 120210000795, 121400000901, 121400000902, 122290000259, 122290000260, 122290000261, 122290000262, 122380000700, 122380000701, 122460000204, 122460000205, 122460000206, 122500001005, 123270000162, 123270000163, 123270000164, 123270000165, 123280001082; xxx) QR-6AC-AXXXX, UDI/DI 00732094263961, Serial Numbers: 116350525090; yyy) QR-6AC-XXXXX, UDI/DI 00812345027686, Serial Numbers: 116280506967, 117090555754, 117520603624, 117520603625, 117520603626, 117520603627, 117520603628, 118360000411, 119210001309, 122400001267, 123290000224; zzz) QSERV-6AA-XXXXB, UDI/DI 00812345027723, Serial Numbers: 116210442893, 116280506968, 117370585104, 117520603131, 117520603629, 117520603132, 118110618488, 118110618489, 118190636540, 118180634599, 118110619531, 118110619529, 118110619530, 118320001194, 118340002364, 118340002365, 118380001950, 11838001950, 118500000657, 119100000504, 118380001951, 119240000466, 119250000167, 119310000759, 119390002491, 119390002492, 119390002493, 119460001342, 119480000721, 119500001540, 120030001174, 120310000229, 120360000152, 120500001270, 121040000709, 121050001720, 121050001721, 121080000529, 121130001982, 121180000664, 121240000844, 121290000691, 121300001846, 121300001847, 121300001848, 121520000393, 121520000394, 122020001772, 122360000027, 122360000028, 122420000161, 123290000507, 123420000668, 10081234502772300; aaaa) QSERV-6AA-XXXXA, UDI/DI 00812345027716, Serial Numbers: 116320522313, 116420532140, 119320000591, 119350003343, 119360000181, 119360000182, 120290001157, 120480000435, 120480000436, 122280000938, 122400001268, 123010001127, 123250000065, 123330000865, 123400000126; bbbb) QS-6GD-CFEAA, UDI/DI 00732094318425, Serial Numbers: 122230001291, 122260000200; cccc) QS-6GA-CDEAA, UDI/DI 00732094300673, Serial Numbers: 121470000320, 121470000319, 118410001021; dddd) QS-6GA-DDEAA, UDI/DI 00732094312874, Serial Numbers: 122260001104; eeee) QS-6FC-XXDAA, UDI/DI 00732094299977, Serial Numbers: 118370002101; ffff) QS-6FC-XXDXA, UDI/DI 00732094313802, Serial Numbers: 121250002003, 121240000679, 121240000678, 121130002175, 121130002174, 121130002173, 121130002172, 120470001107, 120470001106, 120370002064, 120070000198, 119210001602, 119100000464; gggg) QS-6FC-DXDAX, UDI/DI 00732094263251, Serial Numbers: 116250480117; hhhh) QS-6FC-AXDXA, UDI/DI 00817655021881, Serial Numbers: 117360584803, 117360584802; iiii) QS-6FC-DXDAA, UDI/DI 00732094285994, Serial Numbers: 118170632208; jjjj) QS-6FC-DEDAX, UDI/DI 00732094263275, Serial Numbers: 116460537583, 116130381935; kkkk) QS-6FC-DDBAB, UDI/DI 00732094312898, Serial Numbers: 119470002281; llll) QS-6IA-XGDAA, UDI/DI 00732094307818, Serial Numbers: 120530000476, 120380001112, 120290000507, 119020000209; mmmm) QS-6ID-AGDAA, UDI/DI 00817655021935, Serial Numbers: 117380586449, 117380586442, 117380586441; nnnn) QS-6IB-CGEXB, UDI/DI 00732094263213, Serial Numbers: 117360584950, 117240573990; oooo) QS-6ID-AADAB, UDI/DI 00732094296273, Serial Numbers: 118380000431; pppp) QS-6IA-AEDAB, UDI/DI 00817655020754, Serial Numbers: 117020550574; qqqq) QS-6FA-AXDAA, UDI/DI 00732094321012, Serial Numbers: 119260001745; rrrr) QS-6FB-DGEXX, UDI/DI 00732094307245, Serial Numbers: 119020001319, 118500002163; ssss) QS-6FB-DXEXX, UDI/DI 00732094263282, Serial Numbers: 118190635508, 118110620689, 118110620688, 118110620687; tttt) QS-6FA-CEDXA, UDI/DI 00732094353587, Serial Numbers: 123120000945, 123120000944; uuuu) QS-6FA-DEDXA, UDI/DI 00732094301717, Serial Numbers: 118460002308; vvvv) QS-6EC-XXDXX, UDI/DI 00732094263305, Serial Numbers: 121270000364, 120400002610, 120400002609, 119330000824, 119330000823, 119330000822, 119180001175, 119180001174, 118430001468, 118430001467, 118430000951, 118430000950, 118310001204, 118310001203, 118310001202, 118310001201, 118310001200, 118310001199, 118070612444, 118070612443, 118070612442, 118070612441, 118070612440, 118070612439, 118070612438, 118070612437, 118070612436, 118070612435, 118070612434, 118070612433, 117120556943, 117120556942, 117120556941, 117120556940, 116130378850; wwww) QS-6EC-AXDXA, UDI/DI 00732094263350, Serial Numbers: 116180416556; xxxx) QS-6EC-XXDXA, UDI/DI 00732094263312, Serial Numbers: 123050000817, 123050000816, 123050000815, 123010001124, 123010001123, 123010001122, 122490000193, 122220000687, 122050000151, 122050000150, 122050000149, 121330001325, 120070002049, 119270000050, 119270000049, 119210000209, 119210000208, 119020000208, 119020000207, 116240458285, 116210440142, 116190425268; yyyy) QS-6EC-XGDAA, UDI/DI 00732094263329, Serial Numbers: 117160563896; zzzz) QS-6EC-DGEAB, UDI/DI 00732094343786, Serial Numbers: 122020001211, 122020001210, 122020001209, 122020001208, 122020001207, 122020001206, 121050000573, 121040000879, 121040000878, 121040000877, 121040000876, 121040000875, 121040000874, 121040000873, 121040000872, 121040000871, 121040000870, 121040000869, 121040000868, 121040000867, 121040000866, 121040000865, 121040000864, 121040000863, 121040000862, 121040000861, 121040000860, 120520000677, 120520000676, 120520000675, 120520000674, 120520000673, 120520000672, 120520000671, 123280000371, 123280000372, 0.123280000371; aaaaa) QS-6EC-DGEAA, UDI/DI 00732094294026, Serial Numbers: 118480000815, 118480000817, 11840000816, 118320001188, 118320001187, 118320001186, 118480000816; bbbbb) QS-6EC-DXEXB, UDI/DI 00732094263336, Serial Numbers: 118110620686; ccccc) QS-6EC-DFDAA, UDI/DI 00732094263343, Serial Numbers: 119050000685, 117360584972; ddddd) QS-6EC-DFEAB, UDI/DI 00732094312928, Serial Numbers: 122360000843, 123430001428, 123430001429, 123460001117, 123460001118; eeeee) QS-6EC-DFEAC, UDI/DI 00732094318074, Serial Numbers: 122370001542, 122370001541; fffff) QS-6EC-CFEAA, UDI/DI 00732094318463, Serial Numbers: 123060000570, 122360000842, 122360000841, 122360000840, 122290000258, 122290000257, 121450000732, 121220000158, 123020001494; ggggg) QS-6EC-DBEAB, UDI/DI 00732094312942, Serial Numbers: 120180000468, 120180000467, 120180000466, 120180000465, 120180000464, 120180000463, 120180000462, 120180000461, 120030000552, 120030000550, 120030000549, 120030000548, 120030000547, 120030000551; hhhhh) QS-6EC-ACDAX, UDI/DI 00732094263367, Serial Numbers: 117080555094; iiiii) QS-6EC-ACAAB, UDI/DI 00732094263381, Serial Numbers: 116450536622, 116450536621, 116400530032, 116400530031, 116400530030, 116400529513, 116400529512, 116160400845, 116160400843, 116160400841, 116160400812; jjjjj) QS-6EC-ACDAB, UDI/DI 00732094263374, Serial Numbers: 122460001567, 122460001566, 122460001565, 121410001268, 121410001267, 121410001266, 121410001265, 121050000580, 121050000579, 120110000603, 120110000602, 120110000601, 120110000600, 120110000599, 120010000189, 120010000188, 120010000187, 120010000186, 120010000185, 119330000821, 119330000820, 119330000819, 119330000818, 119330000817, 119330000816, 119330000815, 119330000814, 119330000813, 119330000812, 119330000811, 118450001241, 118450001240, 118450001239, 118450001238, 118450001237, 118450001236, 118450001235, 118450001234, 118450001233, 118340000119, 118340000118, 118340000117, 118340000116, 118340000115, 118340000114, 118340000113, 118170632609, 118170632608, 118100617936, 118100617935, 118100617934, 118090616243, 118090616242, 117170565096, 117170565095, 117170565094, 117170565093, 117170565092, 117050553502, 117050553501, 116520545399, 116520545398, 123370000157, 123370000158; kkkkk) QS-6GC-DXEXB, UDI/DI 00732094263237, Serial Numbers: 122410000834, 117500600524; lllll) QS-6GD-AGDAA , UDI/DI 00732094319934, Serial Numbers: 119230000091, 119230000090; mmmmm) QS-6GD-XGDAA, UDI/DI 00817655021331, Serial Numbers: 120080002226, 119460000139, 119450000816, 119340000340, 119220001050, 117120556596; nnnnn) QS-6GD-AFDAX, UDI/DI 00732094263220, Serial Numbers: 116430533401; ooooo) QS-6GD-CAEAB, UDI/DI 00732094289169, Serial Numbers: 118480000818, 118460002309, 118290001244; ppppp) QS-6GA-ACDAA, UDI/DI 00732094263244, Serial Numbers: 118040608357, 117490599297; qqqqq) QS-6GD-CDEAB, UDI/DI 00732094308426, Serial Numbers: 123270000832; rrrrr) QS-6EB-DXDXX, UDI/DI 00732094263404, Serial Numbers: 116510545329, 116510545328, 116510545327, 116510545326; sssss) QS-6EB-BXDXA, UDI/DI 00812345027693, Serial Numbers: 116110349246; ttttt) QS-6EB-DGEXX, UDI/DI 00732094321203, Serial Numbers: 119300000702; uuuuu) QS-6EB-DGEAB, UDI/DI 00732094315660, Serial Numbers: 121340000884, 120300000079, 120110000693, 120110000692, 119270000110, 119270000109, 119140000184; vvvvv) QS-6EB-DGEAC, UDI/DI 00732094296167, Serial Numbers: 118500000531, 118340000583, 118340000582, 118340000581, 118340000580; wwwww) QS-6EB-DXEXB, UDI/DI 00732094263398, Serial Numbers: 118210639085, 118110620685; xxxxx) QS-6EB-CFDAB, UDI/DI 00732094263411, Serial Numbers: 117290578773; yyyyy) QS-6ED-AEAAB, UDI/DI 00812345027624, Serial Numbers: 116170411442, 116170411440; zzzzz) QS-6ED-XFDAB, UDI/DI 00732094352672, Serial Numbers: 122310001547; aaaaaa) QS-6ED-AEAAA, UDI/DI 00732094355543, Serial Numbers: 123410000306, 123410000307, 123410000308, 123410000309, 123410000310, 123410000311; bbbbbb) QS-6ED-XEDAA, UDI/DI 00732094308495, Serial Numbers: 120230000441, 119310001145; cccccc) QS-6EA-DFEAB, UDI/DI UDI/DI 00732094263428, Serial Numbers: 122490000192, 122490000191, 122360000839, 120360000449, 120330000900, 117120556935, 117120556934, 117060553847, 116120375035, 116120375032; dddddd) QS-6ED-CFEAB, UDI/DI 00732094318432, Serial Numbers: 120050000650, 120050000649, 120050000648, 120050000647, 120050000646; eeeeee) QS-6ED-DFEAB, UDI/DI 00732094312904, Serial Numbers: 121400000051, 121400000050, 121400000049; ffffff) QS-6ED-CFEAA, UDI/DI 00732094313918, Serial Numbers: 121300001279; gggggg) QS-6ED-CBEAA, UDI/DI 00732094263299, Serial Numbers: 117200568394; hhhhhh) QS-6EA-ACDAA, UDI/DI 00732094302110, Serial Numbers: 118470000477; iiiiii) QS-6EA-CDEAB, UDI/DI 00732094263435, Serial Numbers: 117310581163; jjjjjj) QS-6ED-CDEAB, UDI/DI 00732094309645, Serial Numbers: 119080001408, 119080001407
Recalling Firm/
Manufacturer
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
FDA Determined
Cause 2
Software design
ActionBaxter issued an Urgent Medical Device Correction notice to its consignees on 12/08/2023 via USPS first class mail. The notice explained the problem, hazard involved, requested the following actions be taken until a software update becomes available: - Clinicians should evaluate the potential impact of the SCF as described to determine if it should be enabled or disabled during stress testing and provided the method for disabling the setting. - If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them, informing them of the requirement to evaluate the potential impact of the SCF during stress testing. - Respond using the customer portal: https://BaxterFieldActionCustomerPortal.onprocess.com. - If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal. - If you purchased this product from a distributor, please note that the Baxter reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to your distributor/wholesaler according to their instructions. For general questions regarding this communication, contact Baxter (legacy Welch Allyn and Hillrom) Customer Service at 800-535-6663, Option 1, or Option 2 for Technical Support, between the hours of 8:00 am and 8:00 pm Eastern Time, Monday through Friday.
Quantity in Commerce4687 units
DistributionUnited States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei, Chia, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Thailand, Algeria, Angola, Austria, Bahrain, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Argentina, Bahamas, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, and Trinidad and Tobago.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DPS
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