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U.S. Department of Health and Human Services

Class 2 Device Recall Vivid i

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  Class 2 Device Recall Vivid i see related information
Date Initiated by Firm November 10, 2022
Date Posted December 22, 2022
Recall Status1 Open3, Classified
Recall Number Z-0756-2023
Recall Event ID 91139
510(K)Number K033139  K061525  K082374  K092140  K102388  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062).

Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and
pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology
(including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative
(abdominal, thoracic, and vascular).
Code Information Model Number (System ID): H45021A (VI4552, VI351); H45021AF (VI1246, VI327, VI1415, VI256, VI00887, VI1119, VI000832, VI0468, VI666, VI1658, VI1263, VI1676, VI1673, VI1261, VI689, VI921, VI1148, VI511, VI050852, VI1295, VI1166, VI1247, VI1536, VI730, VIMB00435, VI431, VI2397, VI1029, VI554, VI1020, VI0658, VI1432, VI51073, VI880, VI1199, VI994, AVHSE20751, VI311, VI379, VI1256, VI1214, VI345, VI193, VI336, VI1097, VI853, VI1488, VI848, VI1017, VI739, VI1258, VI248, VI732, VI148, VI1410, VI1234, VI697, VIR55546, VI153, VI562, EPSW59BF, VI1452, VI669, VI342, VI1118, VI1259, VI1529, VI1394, VI055240, VI963, VI651, VI1437, VI1517, VI50194, VI257, VI824, VI621, VI622, 393204, VI623, VI0579, VI1446, VI1552, VI374, VI906, VI1241, VI132, VI797, VI907, VI1236, VI1565, VI638, 912535VIVID, VI1321, VI526, VI258, VI261, VI50588, VI303, VI000459, VI000228, VI914, VI055696, VI1600, VI816, VI896, VI684, VIV0704, VI1240, VI365, VI358, VI653, VI230, VI680, VI480, VIMB000788, VI1205, 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A6034501, A174938102, A173180601, A5101451, A5101450, A5101452, A5343504, UA7400, UA7345, UA6224, UA6260, UAA433, UA8474, UA6262, UA7322, UAA106, UA6178, UA8436, UA6201, UA8421, UA6253, UA6265, UA6225, UA8470, UA7292, UA5160, UA7350, UA7389, UA8446, UA8471, UA6190, UA7402, UA7311, UA8465, UA7382, UA6212, UA7376, UA7286, UA8449, UA8408, UA6214, UA7313, UAA403, UAA219, UAA369, UA7354, UA7353, UA8412, UA6254, UA6275, UAA175, UA6272, UA7365, UA6252, UA6234, UA7321, UAA130, UA7351, UA8462, UA6186, UA6235, UA8441, UAA249, UA6261, UA6229, UAA337, UAA621, UA5107, UA5141, UA8438, UA5133, UAA284, UA5108, UA5123, UAA208, UAA405, UA7363, UA5145, UA6195, UAA104, UA8447, UA5152, UAA207, UA6189, UA8464, UA6246, UA6257, UA6180, UA7362, UA7285, UA5161, UA5113, UA6270, UA7398, UAA368, UAA250, UA7386, UA7327, UA7340, UA5112, UAA431, UA6226, UA8469, UA8413, UA5119, UA8458, UAA131, UA7324, UA7301, UA5144, UA5166, UA6276, UA7379, UA7319, UA6259, UA6210, UA5140, UA5129, UA7295, UA7316, UA8423, UA5128, UA8429, UA8435, UA6199, UA7297, UA8467, UA6204, UA7279, UA7346, UA5110, UA7342, UA7384, UA6266, UA5121, UA5111, UA7383, UA8468, UA5170, UAA367, UAA169, UAA331, UA7380, UA8419, UA7375, UA6213, UAA222, UA7314, UA7352, UAA126, UA5154, UA5136, UAA432, UA7296, UA6263, UA7385, UA8407, UA6231, UA7348, UA5116, UAA310, UA7395, UAA430, UA7366, UA5162, UA8459, UAA434, UA7377, UA6194, UA6241, UAA102, UA7312, UA6242, UA7397, UA8418, UA6228, UA8437, UA7325, UA7326, UA6258, UA7304, UA7305, UA5139, UAA339, UA8463, UA7320, UAA165, UA6240, UA5120, UA7341, UA8466, UA7364, UA4063, UA5122, UA8417, UA7315, UA7291, UA6230, UA5117, UA6209, UA7391, UA5143, UAA330, UA6255, UA7392, UA6273, UA7299, UA7355, UA8452, UA6216, UA7399, UA7323, UA6223, UA7396, UA6243, UA7357, UA7393, UA6183, UA6239, UA6227, UA6184, UA8416, UA7390, UA6247, UA6244, UA6238, UA6215, UA8426, UA8411, UA6245, UA6233, UA6237, UA8440, UA8461, UA7289, UAA282, UA7328, KA2912US02, 0850US4149, 0850US5925, 0850US4333, 0850US4458, 0850US7009, 0850US6292, 0850US4265, 0850US5918, 0850US5926, 0850US5927, 0850US4360, 0850US4470, 0850US4801, 0850US4260, 0850US4493, 0850US5057, 0850US4292, 0850US4479, KW1081US01, LT4000US16, LT4000US15, 815992US01, MU1019US01, VI21275VI, VI1130, VI030112VI, VI4447VI, AMS2740, AMS1042, DVT0145, DRK0140, DTC0144, HOR0240, LSM0140, LWD0345, LDN0540, RRM0240, TIL0141, TLB0244, WIN0142, 0920369271, NO4054US11, NO4010US03, NO4145US03, NO4006US07, NO4026US08, NO4043US05, NO4005US81, NO4088US19, NO4068US33, NO4134US06, VI1543, 0843384033, PL6397US02, PL1027US04, PL2255US02, PL6330US01, PL1107US09, PL1840US02, PL7916US01, PL1006US30, PL1006US45, PL4430US02, PL4430US03, PER18203, PER18510, PPR84500, PER50315, PPR102200, PPR86700, RU1556US17, GEKAZAUS02, RU2707US03, RU4325US02, RU2741US47, RU2741US48, RU2741US49, RU1706US10, SA2087US03, 0847384034, ZA2200US01, NE209933, DEL26434, ME256649, DE641220, DEN51303, CE561217, CE561218, DED64780, DEN00104, MEX61735, YP642102, DE669622, DE669627, NE223227, S005US01, O009US10, O005US06, M007US03, T002US03, P007US02, R001US13, A051US01, A044US08, A072US01, A051US03, A069US01, A044US09, 437918US01, 446162US02, 103000US02, 505100US02, 756020US01, 893020US04, 509522US02, 0856380031, 0856380042, 0856380044, 0856380045, 0856380065, 0856380299, 0856380047, 0856380040, 0856380035, 0856380036, 06233ULT02, 99999ULT15, 99999ULT23, 34006ULT04, P34382UL01, P33015UL05, AE1006US07, AE1140US04, IE1513US11, 00991ULT07, 00507ULT01, 10100ULT15, 00060ULT09, 1917592356, 00432ULT18, 00432ULT17, IE1505US06, 00084ULT07, 10597ULT01, 00095ULT35, 00020ULT09, VI021194VI, VI030002VI, VI030062VI); H45021AG (VIMB4908, VI3832, VI4687, VI3461, VI2647, VI3732, VI3432, VI2885, VI3857, VI2741, VI1563, VI4612, VI3933, VI3528, VI3408, VI3543, VI4551, VI4256, VI3918, VI3866, VI3610, VI3514, VI2116, VI3573, VIMB3678, VI4650, VI2825, VI2154, VIV4533, VI4127, VI3440, VI3492, VI3639, VI4527, VI3441, VI4262, VI2620, VI3410, VI3634, VI2474X2, VI1774, VI3424, VI3954, VIR1680, VI1043, VI2487, VI2500, VI2645, VI1949X, VI2663, VI4513, VI3299, VI20799CART, VI20801CART, VI3081, VI3142, VI3769, VI2950, VI4261, VI4669, VI3558, VI2325, VI4307, VI2747, VI2754, VI1047, VI4276, VI3453, VI3869, VI2760, VI3908, VI2822, VI3654, VI4338, VI3686, VI3451, VI2832, VIR3427, VI3537, VI3083, VI3593, VI3498, VI3077, VI2168, VI3415, VI1904, VI2764, VI4671, VI3902, VI4097, VIVID1003A, VI4317, VI4285, VI3692, VI4132, VI2910, VI2774, VI4215, VI3466, VI3145, VIR1859, VIR4090, VI4575, VI2983, VI4658, VI3401, VI3447, VI4108, VI3422, VI3653, VI4601, VI3188, VI4673, VI4530, VI4663, VI2292, VI4593, VI4244, VI20837CART, VI3640, VI4386, VI4023, VI2165, VI3197, VI4085, VI4238, VI3970, VI2696, 020991VI, VI2137, VI2136, VI3458, VI419SCART, AH0125US05, 772342US01, 030295US07, VI30604VI, VI30603VI, VI50256VI, VI30605VI, VI30590VI, VI30600VI, 905458VI1, 780450US1, 082438210056, 082438160153, 82438090144, VI50242VI, DK1160US15, DK1023US13, DK1194US03, EE4020US11, FI1023US07, FI1315US01, FI1636US01, FI1000US21, FI1285US03, USM4477103, US88638707, US62664106, USN9190103, US67366323, RE1000US02, 2244997U02, 2397292U01, 145135U008, 145304U020, 122024U018, 145887U002, 100540U010, 100019U019, 2002142U01, 1937574U12, 1702078U02, 120056U018, H5414US01, H2107US01, H2193US20, H2017US10, IE1033US15, B5127423, A5188541, A5183649, KA1155US06, KA1155US08, 0850US6513, AMS3740, LDN0174, RSD0142, ZWL0246, PL6588US14, PL7254US01, PL7454US01, PER19016, RO4164US02, RO4234US04, RU3293US02, RU3280US01, RU3292US01, RU3053US02, RU2739US02, RU4386US03, RU3128US02, RU3644US09, RU2899US01, RU1295US16, RU1834US11, RU2056US04, RU2500US07, RU4192US06, RU4546US05, RU3291US01, RU5494US03, RU6354US02, RU3279US01, RU2741US09, RU6171US02, RU1934US17, RU4489US09, RU2959US01, 0847384064, 847384081, ZA2322US08, ZA2322US10, ZA2322US09, ZA2322US11, ME244348, CEZ00400, S001US13, S001US12, 0856380106, 06213ULT01, 22004ULT01, P25016UL21, P25016UL22, 34001ULT07, AE1005US06, 20441ULT01, 00341ULT01, 21039ULT01, VI003911VI); H45021JK (VIU3862, VI5126, VI3496, VI1899, VI1403, VI2970, VI1685, VI3768, VI2779, VI2099, VI3855, VI1993, VI4388, VI4389, VI3170, VI4401, VI4384, VI2627, VI3087, VI2527, VI1572, VI2868, VI3489, VI2124, VI1598, VI1159, VI0755, VI1044, VI2611, VI2590, VI3430, VI2372, VI1772, VI3181, VI2188, VI1660, VI2109, VI531, VI2539, VI2678, VI2856, VI4229, VI2327, VI4426, VI1943, VI2308, 4420, VI4496, VI969X3, VI121, VI1853, VI20096, VI2386, VI2224, VI3133, VI4512, VI3437, VI002497, VI2128, VI1688, VI4120, VI1901, VI2389, VI2430, VI20353, VI4255, VI3097, VI3446, VI3186, VI3249, VI2883, VI2334, VIMB000496, VI2157, VI2328, VI3530, VI2182, VIR1419, VI2305, VI1806, VI2690, VI4071, VI2515, VI4138, VI1839, VI2004, VI3839, VI1323, VI3570, VI2953, VIR870, VI020917, VI4269, VI2415, VI2413, VI2416, VIMB000687, VI757, VI506, VI765, VI3164, VI786, VI62176, VI584, VI2123, VI1712, VIMB001965, VI2688, VIMB435, VI1796, VIMB001964, VIR021236, VIMB000315, VIMB004174, VIMB000252, VIMB003479, VIMB000823, VI4548, VI3861, 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117027U018, 1742312U03, 103301U774, 14942AU621, 138818U006, 138953U008, 1970580U02, 1471941U04, 800830U572, H5257US01, H2032US12, H5065US02, H5314US11, HU1294US04, 083038825075014, IE1087US03, IE1220US01, IE4174US11, IL4066US01, A6192101, A251398002, A58122120, A5812277, A5279332, A5803919, A218035212, A204194402, B5145205, C5803123, A5645604, A5624138, A5188547, D5109605, A5646803, A5719856, A224857335, A5678714, A6080201, A5404613, A5684349, D5354213, A5109320, UAA602, UA9699, UA9611, UA9734, UA9698, UA9625, UA9701, UAA564, UAA658, UA9673, UA9703, UA9614, UA9622, UA9624, UA9623, UA9716, UA7381, UA9609, UA9618, UA8479, UA9655, UA9705, UA9702, UA9615, UA9682, UA9643, UA9713, UAA672, UA9636, UA9610, UAA568, UAA657, UA9731, UA9642, UA9717, UA8420, UA9621, UAA660, UA9700, UA9662, UA9637, UA9647, UA9649, UAA549, UA9685, UA9663, UA9626, UA9680, UA9707, UA9646, UA9678, UA9704, UAA573, UA9719, UA9688, UA9728, UA9720, UA9689, UA9706, UAC547, UA9679, UAA674, UAA617, UAA522, UA9661, UA9639, KA4029US01, KA1032US06, KA2860US11, KA4075US08, KA4075US05, KA4125US01, KA3064US04, LV4001US10, 834374422, VI21357VI, 2951523, VI020892VI, 2947271, VI030046VI, VI020906VI, 2940543, VI021408VI, VI21214VI, 2913482, VI021042VI, VI30046VI, VI030042VI, AMF0440, ENS0155, ZTP0143, NO4006US08, NO4179US34, VI21438VI, PL7499US01, PL7334US01, PL4427US03, PL1147US01, PL4346US09, PPR67702, PER03007, PER10963, PER10962, PER72104, PPS00300, PER25610, VI20263VI, RO4234US05, RO4234US06, RO4476US01, RU1127US14, RU7384US03, RU2676US02, RU2753US03, RU6672US01, RU1095US14, RU1581US04, RU1175US02, RU2741US26, RU2741US20, RU2741US24, RU2741US18, RU2741US25, RU2741US21, RU2741US22, RU2216US08, RU1482US02, 0847384161, ME645951, ME2443131, MPX11500, ME2443130, FPG13373, CE561232, DEH13572, DE646503, DEH13563, DPB27004, DEN01748, MPX99900, DPN03403, YE626945, CE671333, O010US07, F001US09, S001US15, E012US01, A044US14, A044US18, 697129US01, 794210US08, 0853380197, 0856380158, 0856380188, 0856380224, 0856380152, 0856380149, 0856380173, TN1756US01, UA4189US02, GB1329US01, 21022ULT01, 1-75326872, 1376006432, 10100ULT34, 21325ULT07, 1107299122, 1114543832, VI20474VI, VI20537VI, VI20684VI); H45031FN (VI20807, VQ20462, VI20425, VI30345, 519987VI, 204787VI1); H45031RH (VI21023, VI050431, VI50769, VI21170, VI55571, VI050874, VI50795, VI3962, VI50410, VI50425, VI30352VI, B5659113, B5659112, A5379604, B5719809, 101232US01); H45031YW (VI50112, VI30124, VI50976, VI30016, VIR21239, VI30059, VI030125, VIR50083, VI30350, VI050056, VI050407, VI050579, VI055688, VI50423, VI21389, VI30351, VIR2083LO, VI50104, VI30418, VI30266, VI030085, VI30593, VI21273, VI30077, VI020438, VI30221, VI55058, VI21415, VI30304, VIMB50157, VI30171, VIR20528, VI21337, VI30281, VI30073, VI30265, VIR021186, VI21229, VI30137, VI21381, VI30093, VI30084, VI21310, VI30455, VIRQ21007, VI30142, VI50419, VIR21074, VI30224, VI21383, VI30259, VIR020952, VI030220, VI30017, VI30592, 941925VI, VIR20138, VI21414, VI50141, VI21246, VIMB1266, VIMB002184, VIMB000375, VIMB324, VIMB000268, VIMB1721, VIMB1491, VIMB2852, VIMB5203, VI30536, VI21279, VI21176, VI50564, VI55965, VI55821, VIR50137, VI30230, VI30001, VI30078, VI021289, VI21241, VI30385, VIR4384, VIR3761, VI30255, VI21202, VI55251, VI50111, VI50061, VI21331, VI50252, VIMB000376, VI50578, VI30043, VI30130, VI055048, VI55066, VI30512, VI30518, VI21238, VI030092, VI50068, VI50098, VI30235, VI30089, VI50305, VI021328, VI5180, VI30040, VI50195, VI21345, VI30578, VIR21384, VI30347, VI050993, VI30248, VI50053, VI50057, VI03004, VIR21303XX, VI030397, VI21430, VI30296, VIR21303, VI30377, VI30031, VI30410, VI21291, VI50407, VIR2005, VIR20153, VI50244, VI30575, VI50255, VI55078, VI50197, VI50710, VI21278, VI30339, VI30126, VI30586, VI56242, VI30417, VI55061, VI21351, VIMB314, VIMB317, VI50121, VI050124, VI050968, VI50048, VI30353, VI30357, VI30449, VI30596, VI030087, VI21281, VI21399, VI50123, VI030190, VI21407, VIR20655, VI021306, VI21343, VI21354, VI20649, VI30376, VI715, VI30395, VI21330, VI21224, VI21356, VI30010, VI30012, VI21193, VI30283, VI21189, VI50119, VI50155, VI30544, VI50084, VI21362, VI20779, VI50067, VI21305, VI030252, VIR021100, VI21392, VI30525, VI21355, VI21519, VI50767, VI50725, VI55154, VI30164, VI30558, VI50085, VIV55572, VI21219, VI21266, VI50145, VI55545, VI21420, VI30254, VI050403, VI50370, VI50415, VI55547, VI30207, VI30057, VI030014, VI030162, VI030110, VI30336, VI50091, VI50376, VI30090, VI30386, VI30226, VI030524, VI21292, VIR21258, VI21294, VI30070, VIR20810, VI30477, VI21283, VI20782, VI050367, VI055091, VI055239, VI050733, VI55582, VIR20219, VI50094, VI21192, VI21243, VI21293, VI21322, VI21187, VI30034, VI30027, VI21089, VI50065, VI20365, VI50408, VI50395, 0911373608, AH4001US59, AH0101US98, 710043US01, 930079US01, VI30139VI, VI55357VI, VI55106VI, VI55606VI, VI55584VI, VI55352VI, 604822VI2, 604875VIVIDI7, 604228VI1, 604875VIVIDI8, 604875VIVIDI6, 416580VI2, 403220VI1, 519824VI1, 519824VI, 902424VI2, 902424VI1, 905521VI1, 514934VIVI1, 905371VI1, 613562VI1, 819821VIVI1, 289362VI1, 709778VI2, 778782VI1, 416743VI1, 250721VIV1, 204975VI1, VI30515VI, CZ4015US17, CZ4015US15, CZ4015US16, CZ4001US07, CZ4001US09, CZ4001US10, CZ4001US08, CZ4048US25, CZ4048US23, CZ4048US21, CZ6404US01, DK1085US08, FI1353US02, FI1075US28, FI1075US29, FI1023US16, US98769303, US75547806, US87682314, S129872902, USM2051003, U211379803, USM4500501, USM4161404, USM4186004, U267349401, US26675003, U255473401, U265576601, U221367502, U171884902, U257284001, US12967514, US70837708, U256715601, 1906476U28, 142510U021, 110387U015, 110738U004, 138488U020, 800889U003, 138808U042, 110266U020, 2866150U02, 1714896U07, 2204991U03, 109074U009, 2351427U01, 1610878U11, 145888U005, 145897U012, 1837410U16, 151066U006, EK00001U01, 2386491U02, 2538896U01, 110452U005, 110452U004, 113128U049, 113128U052, 796106U002, 1915916U03, 110907U007, 1686865U01, 109874U003, H2194US05, H5439US01, H5582US01, H5747US01, H4471US02, H1591US04, H5501US01, 828380387, HU1205US01, IL4746US09, IL4032US01, IL4263US09, IL4263US01, IL4263US08, IL4652US16, IL4708US01, IL4764US17, A138109085, A138109076, A138109082, A138109078, A138109081, A6324701, A6144401, A6139401, B5801732, A6107701, A5525325, A6125201, A5174255, A5719866, A5323511, A5115133, A5158188, A5158190, A6135101, A6119901, A5678718, A6144601, A6298701, A5110025, A5194074, KA1188US01, KA1189US01, KA2856US09, KA2856US06, KA2856US08, KA2856US15, KA2856US02, KA3316US04, KA3316US03, VI050971V1, AMS1055, LND0140, MST01402, UDN0147, NO4323US01, NO4179US52, NO4179US56, NO4179US54, NO4179US43, NO4179US49, NO4179US36, NO4179US55, NO4179US35, NO4179US58, NO4179US39, NO4179US50, NO4179US51, NO4179US60, NO4179US59, NO4179US53, PL2731US01, PL8680US01, PL3519US03, PL2631US01, PL6233US05, PL7616US01, 600042US27, PER18516, PPS12300, PER00227, PES05808, PES05818, RO4547US03, RO4768US01, RU1016US05, RU2096US05, RU1000US17, RU3907US01, RU4927US03, RU1716US03, 600100US02, RU1385US03, RU1332US15, RU2077US03, RU1152US14, RU1999US17, DPN02300, MPX02300, CPZ43627, DE619853, MPD12600, DPN95300, DPN42501, DPN17300, MEX68985, UE535A115, DPN71402, CEZ00313, 505100US04, 475260US06, 691302US02, TN1641US03, 01098ULT01, 00626ULT16, 00285ULT25); H45031YY (4796, VI4503, VI1595, VQR20098, PL7966US01, 0853380308); H45041A (VI020924VI, 091136DEMO2569, 0911367266, 0911365715, 0911365783, 0911363915, 0911364003, 0911373678, 0911365685, 0911365796, 0911365677, 0911367228, 0911373671, 0911367331, 0911369263, 0911369278, AP6258US02, 774699US02, VI50444VI, VI51010VI, VI50911VI, VI21416, VI55428VI, VI55080VI, VI30456VI, VI055367VI, VI30521VI, VI055076VI, VI50466VI, VI55146VI, VI30587VI, VI50514VI, VI50518VI, VI55138VI, VI55214VI, VI50988VI, VI51063VI, VI21269VI, VI50758VI, VI55220VI, VI21244VI, VI55092VI, VI55699VI, VI55499VI, VI55371VI, VI55426VI, VI51018VI, VI51042VI, VI55075VI, VI30030VI, VI50904VI, VI165862WX4, VI055365VI, VI50807VI, VI55299VI, VI50853VI, VI50759VI, VI55420VI, VI55513VI, VI4362VI, VI50753VI, VI30028VI, VI51037VI, VI50932VI, VI55077VI, VI50497VI, VI055099VI, VI20551VI, VI30462VI, VI50436VI, VI50443VI, VI55150VI, VI30497VI, VI4325VI, VI30500VI, VI50442VI, VI30474VI, VI50496VI, VI55368VI, VI55116VI.VI55142VI, VI50517VI-1, VI55304VI, VI050077VI, VI50756VI, VI55094VI, VI55500VI, VI21287VI, VI21247VI, VI55501VI, VI55081VI, VI50983VI, VI55512VI, VI30431VI, VI50987VI, VI050704VI, VI51055VI, VI55457VI, VI55074VI, VI55709VI, VI55486VI, VI55456VI, VI55436VI, VI55454VI, VI55234VI, VI55461VI, VI55445VI, VI55185VI, VI55497VI, VI55450VI, VI55102VI, VI050934VI, VI050716VI, VI050894VI, VI50449VI, VI50748VI, VI50399VI, VI021458VI, VI50316VI, VI021161VI, VI020893VI, VI020889VI, VI30250VI, VI020994VI, VI21440VI, VI30344VI, VI30527VI, VI050745VI, VI50153VI, VI050844VI, DK1283US01, VI30143VI, VI30015VI, U100324707, U178502602, U259298201, 110387U019, 110767U031, 110783U066, 2866150U01, 110221U003, 110814U003, 802786U106, 2095056U02, 138658U011, 122009U053, 2515882U01, 2498496U03, 109690U009, 120189U007, H1404US18, H5707US01, 600117US04, HU1294US05, HU1577US02, HU1037US01, IS1014US01, 083038240145712, 083038240146012, 083038241019712, 083038241019713, 083038241151311, 083038200126913, 083038841695618, 083038821036612, 083038840501512, 083038001183012, 083038801016412, 083037021177712, 083038801122011, 083038201056411, 083038601123211, 083038020172312, 083038061073211, 083038061164111, 083038100301312, 083038801120111, B5167328, A5195211, A140417602, B5174211, A652832701, A5158191, A5158189, A51152185, A174339802, A5183650, A5115816, UA9890, UA9872, UAA684, UA9913, UA9922, UA9737, UA8445, UAA843, UA9909, UA9871, UA9860, UA9805, UA9859, UA9772, UA9829, UA4064, UA9741, UA7307, UA9901, UA9921, UA9819, UA9785, UAA782, UA9863, UA9861, UA9760, UA9791, UA9810, UA9882, UA9919, UA9873, UA9752, UA6269, UAA766, UA9755, UA9750, UA9804, UA9869, UA9908, UA9827, UA9786, UA9523, UA9854, UA9738, UA9756, UA9739, UA9774, UA9778, UA9777, UA9892, UA9798, UA9907, UA9900, UA9753, UAA729, UAA675, UA9903, UA9936, UA9917, UAA659, UA9809, UA9916, UA9895, UA9904, UA9794, UA9757, UAA839, UA9865, UA9852, UA9870, UAA767, UA9849, UA9933, UA9836, UAA784, UA9943, UA9799, UA9850, UA9920, UA9881, UA9627, UAA732, UA9935, UAA765, UA9934, UA9807, UA9853, UA9947, UA9942, UA9831, UA9826, UA9911, UA9718, UA9828, UA9918, UA9835, UAA695, UA9837, UAA691, UA9800, UAA758, UAA783, UA9754, UA9949, UA9929, UA9937, UA9888, UA9780, UA9938, UA9868, UAA875, UA9851, UA9902, UA9941, UA9950, UAA692, UA9862, UA9931, UA9930, UA9932, UA9889, UA9825, UA9830, UA9693, UA9536, UA9818, UA9740, UAA838, UA9771, UA8414, UA9817, UA9939, UA9730, UA9864, UA9751, UA9801, UA9787, UA9793, UA9811, UA9891, UA9944, UAA773, 0850US7941, 0850370068, VI030099VI, VI055412VI, VI135110PD5, VI030081VI, VI030098VI, VI30098VI, VI050971VI, VI050897VI, VI050963VI, VI21482VI, VI030008VI, VI030149VI, VI055462VI, 0920369259, NO4179US38, NO4179US65, NO4179US40, NO4179US57, NO4179US42, NO4179US61, NO4179US62, NO4179US63, VI21443VI, PL3593US02, PL1541US12, PL2055US03, PL0983US01, PL1610US02, PL1951US01, PL3920US01, PER10974, PER00231, PPR05013, VI21092VI, VI030413VI, VI050802VI, VI21080VI, VI21087VI, RU7288US02, RU9800US01, RU3944US01, RU1158US20, RU1991US06, RU3880US06, RU3880US05, RU1558US06, RU1232US02, RU2762US03, RU7859US01, RU2275US06, RU1012US06, RU3914US01, RU7355US02, RU1057US10, RU7302US02, RU3790US01, 600105US03, RU3951US01, RU1999US20, RU1999US15, RU3998US05, RU3176US03, RU3176US12, 6073UL0034, 6073UL0039, 6073UL0033, 6073UL0213, 6073UL0035, 0847384438, 0847384443, 0847384447, 0847384471, CPZ43626, CPZ43614, GPX39200, FE457A78, P005US02, 0856380209, 0856380210, 0856380211, 0856380215, 0856380219, 0856380223, 0856380230, 0856380238, 0856380239, 0856380249, 0856380258, GB1160US02, 1509734247, 20010ULT07, 1817792272, 1384786134, 1805009562, 1455524996, 10134ULT16, 1753766112, 1390028954, GB1274US01, VI21313VI, VI20775VI, VI020833VI); H45041CJ (EPPC3523, VI30583, VI21388, VI020052, VI21166, VI2078, VI2072, VI050522, VI30598, VI3554, VI20360, VQ20738, VQ20736, VQ20740, CZ6026US38, DPN22800); H45041EA (VI055401VI, VI30530VI, VI50205VI, VI30607VI, VI30619VI, VI30624VI, VI30618VI, VI50283VI, VI050776VI, VI50525VI, VI021472VI, 00658ULT01, 00168ULT19, VI051064VI); H45041EB (VI55316VI, VI50229VI, VI30622VI, VI21505VI); H45041ED (VI50021VI, VS63922VS6, VI50751VI, VI50101VI, VI50118VI, VI4375VI, VI50049VI, 083038024024313, 20587ULT01, 21112ULT01); H45041EE (IE1010US16, ZA1025US24, MPX08300); H45041EP (VI55079, VI50433); H45041F (VI56117, VI55120, VI51076, VI56770, VI56092, VIR50565, VI56798, VI55524, VI50718, VI50706, VI56056, VI50739, VIR50428, VI50952, VI56052, VI55958, VIR2078, VIR50952, VI55517, VI021396, VI55443, VIV56767, VI56224, VI56175, VIV002427, VIR50939, VI55777, VI55790X, VI56109, VIR56260, VI56165, VIR20140, VI55439, VI55551, VI56666, VI55237, VI56727, VI56789, VI51060, VIR3147, VI51065, VIR51051, VI56286, 055595VIV, VIV002070, VIV55329, VI56033, VI56289, VI55601, VIR55418, VI55797, VSI302, VI56071, VIMB56799, VI56008, VI55791, VIR50837, VI56547, VI56812, VIR50446, VI55166, VI55325, VI56006, VI50836, VI55987, VI55914, VIR56192, VI56464, VI56047, VI56536, VI56726, VI56178, VI55795, VI55029, VI56793, VI55539, VI50583, VIR51072, VI50402, VI56263, VI55442, VI055442, VI51092, VI56053, VI56055, VI56236, VI56468, VI56594, VI50552, VIR55583, VI55550, VIR51041, VIR55291, VI56785, VI56597, VI56596, VIR1951, VI55022, VI55379, VI50456, VI50512, VI56757, VI56598, VI56738, VI50962, VIR056655, VI56088, VI51080, VI51020, VI56724, VIR055993, VI50563, VIR56403, VI56257, VI55320, VIR21340, VI56696, VIR55553, VIR56167, VI56638, VI55860, VIMB802, VEMB90405, VI055479, VI56636, VI50279, VI56176, VI56663, VIV56667, VI51103, VI50957, VI50930, VI50771, VI55353, VI56246, VI50845, VI56713, VIMB56591, VI50860, VI56756, VI55327, VIR1266, VI50851, VI56207, VI56287, VI56698, VI55859, VI55161, VI56589, VI56462, VI50850, VI050595, VI050731, VI51036, VI56066, VI56291, VIR50327, VIR50453, VI50940, VI3677, 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083038825864914, 083038840059814, 083038820009313, 083038801054513, 083038801054613, 083038801071512, 083038820015214, 083038820003613, 083038201068713, 083038820003212, 083038240068213, 083038061055313, 083038241019513, 083038801054913, 083038801055213, 083038801054713, 083038801055013, 083038801055113, IE1249US01, A6209701, A141169502, A141169503, A6255701, A5204012, A6265401, A6107502, A6107503, A6107505, UA0288, UA0233, UA0050, UA0300, UA0183, UA9993, UA0039, UAA062, UAA034, UA9990, UA0219, UA0200, UA0256, UA0155, UAA261, UA0268, UA0197, UA0063, UA0064, UA0232, UA0266, UAA840, UA0222, UAA953, UA0187, UA0042, UA0234, UA0044, UAA910, UA0185, UA0294, UA0277, UA0264, UAA656, UA9997, UAA125, UA0163, UA9641, UA0153, UA0027, UA0280, UA0051, UA0304, UA0038, UA0067, UA8498, UA0172, UA0122, UA9612, UA0158, UA0167, UA0083, UA0113, UAA961, UAA906, UAA218, UA9714, UAA217, UA9998, UA0281, UA0055, UAA032, UA9967, UA0293, UA0175, UA0296, UA0048, UA0010, UA0208, UA0289, UA0099, UA9648, UA0282, 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AE1011US10, AE1034US04, AE1249US01, AE1007US16, AE1031US06, AE1036US06, AE1017US10); H45571ZT (VI50117, VI20900, VI56588, VI3957)
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
FDA Determined
Cause 2		 Device Design
Action GE Healthcare notified consignees on about 11/10/2022 via letter titled "URGENT MEDICAL DEVICE CORRECTION. For U.S. customers, letters were sent via FedEx. Consignees were instructed to follow updated safety instructions provided in the appendix included with the notification letter, place the appendix with the product labeling, and replace the batter every 2 years or if the battery is not capable of powering the system for more than 30 minutes. In response, GE Healthcare requested consignees return the response form.
Quantity in Commerce 7,931 units
Distribution Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, AZERBAIJAN, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chile, CHINA Colombia, CONGO, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, CZECH REPUBLIC, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, HONG KONG, Hungary, ICELAND, INDIA, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Kuwait, KYRGYZSTAN, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, LUXEMBOURG, Macedonia, MALAYSIA, Mali, Mauritania, Mauritius, Mexico, MICRONESIA, Moldova, Morocco, Mozambique, Namibia, Nepal, Netherlands, NEW ZEALAND, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, SYRIA, TAIWAN, TANZANIA, THAILAND, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = ITX and Original Applicant = GE MEDICAL SYSTEM ISRAEL LTD.
510(K)s with Product Code = ITX and Original Applicant = GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
510(K)s with Product Code = ITX and Original Applicant = GENERAL ELECTRIC CO.
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