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U.S. Department of Health and Human Services

Class 2 Device Recall BV Pulsera R2.2 Mobile Xray system

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 Class 2 Recall
BV Pulsera R2.2 Mobile Xray system
see related information
Date Posted October 25, 2010
Recall Status1 Terminated on December 07, 2010
Recall Number Z-0140-2011
Recall Event ID 49605
Premarket Notification
510(K) Number
K010435 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device's brochure is labeled in part: "Philips...Mobile C-Arm systems BV Pulsera".
Code Information 1331 units are identified with Site numbers: 541547, 541556, 541557, 541558, 542423, 542426, 542427, 542584, 542684, 542769, 542854, 543059, 543219, 543220, 543222, 543458, 543459, 543460, 543461, 543462, 543463, 543464, 543465, 543561, 543562, 543616, 543828, 543862, 543947, 544191, 544301, 544367, 544396, 544411, 544456, 544457, 544458, 544459, 544460, 544461, 544462, 544463, 544464, 544465, 544466, 544467, 544469, 544470, 544471, 544473, 544474, 544475, 544476, 544533, 544562, 544603, 544622, 544905, 544925, 544926, 544972, 544984, 545032, 545039, 545085, 545102, 545103, 545136, 545139, 545140, 545284, 545397, 545492, 545631, 545751, 545822, 545922, 545924, 545961, 545996, 546026, 546086, 546145, 546461, 546508, 546516, 546531, 546579, 546580, 546680, 546687, 546786, 546788, 546790, 546791, 546851, 546999, 547000, 547082, 547169, 547171, 547172, 547199, 547221, 547284, 547288, 547298, 547299, 547349, 547350, 547351, 547352, 547375, 547602, 547603, 547604, 547605, 547606, 547643, 547656, 547684, 547710, 547712, 547746, 547790, 547791, 547805, 547839, 547975, 548004, 548104, 548246, 548308, 548309, 548354, 548358, 548366, 548385, 548397, 548398, 548399, 548569, 548602, 548614, 548653, 548700, 548702, 548731, 548733, 548743, 548781, 548782, 548790, 548853, 548929, 548972, 548975, 548984, 548992, 548996, 549005, 549006, 549021, 549025, 549027, 549049, 549059, 549060, 549061, 549063, 549064, 549065, 549070, 549071, 549072, 549081, 549089, 549112, 549113, 549114, 549115, 549116, 549117, 549118, 549119, 549120, 549121, 549122, 549125, 549126, 549127, 549128, 549129, 549130, 549132, 549133, 549136, 549137, 549139, 549140, 549142, 549143, 549144, 549171, 549207, 549218, 549221, 549231, 549235, 549241, 549260, 549262, 549272, 549273, 549274, 549275, 549287, 549301, 549390, 549397, 549403, 549404, 549405, 549406, 549407, 549519, 549520, 549528, 549540, 549563, 549583, 549596, 549618, 549632, 549674, 549694, 549706, 549708, 549727, 549728, 549732, 549733, 549749, 549752, 549758, 549773, 549822, 549855, 549878, 549964, 549968, 549993, 550022, 550023, 550056, 550066, 550113, 550121, 550123, 550125, 550128, 550131, 550136, 550183, 550184, 550186, 550189, 550190, 550200, 550252, 550264, 550298, 550372, 550379, 550416, 550426, 550427, 550428, 550450, 550523, 550524, 550541, 550542, 550551, 550562, 550603, 550649, 550651, 550653, 550728, 550762, 550805, 550808, 550809, 550819, 550820, 550822, 550840, 550844, 550847, 550856, 550865, 550875, 550879, 550923, 550925, 550971, 550982, 551013, 551020, 551023, 551024, 551033, 551034, 551039, 551128, 551132, 551133, 551134, 551135, 551136, 551137, 551139, 551142, 551190, 551191, 551212, 551262, 551264, 551277, 551292, 551293, 551300, 551329, 551331, 551332, 551333, 551366, 551367, 551368, 551369, 551373, 551381, 551384, 551388, 551400, 551422, 551425, 551427, 551428, 551444, 551445, 551473, 551475, 551476, 551478, 551487, 551506, 551507, 551513, 551518, 551524, 551528, 551529, 551530, 551531, 551532, 551533, 551534, 551536, 551537, 551538, 551539, 551546, 551547, 551548, 551549, 551580, 551591, 551592, 551594, 551605, 551621, 551624, 551646, 551685, 551686, 551687, 551688, 551712, 551713, 551723, 551729, 551764, 551797, 551813, 551820, 551822, 551840, 551854, 551882, 551885, 551952, 551967, 551992, 552014, 552015, 552016, 552017, 552018, 552034, 552070, 552075, 552103, 552113, 552121, 552122, 552157, 552161, 552182, 552225, 552226, 552228, 552229, 552230, 552231, 552232, 552233, 552234, 552235, 552236, 552237, 552239, 552240, 552241, 552242, 552243, 552244, 552245, 552246, 552247, 552248, 552249, 552250, 552251, 552262, 552265, 552291, 552292, 552297, 552298, 552299, 552308, 552310, 552312, 552327, 552334, 552335, 552336, 552365, 552386, 552387, 552401, 552402, 552403, 552405, 552406, 552439, 552445, 552452, 552459, 552460, 552462, 552471, 552483, 552510, 552511, 552525, 552542, 552547, 552561, 552565, 552566, 552569, 552573, 552578, 552581, 552606, 552618, 552621, 552632, 552638, 552642, 552643, 552670, 552678, 552688, 552689, 552690, 552715, 552716, 552722, 552723, 552724, 552739, 552740, 552840, 552841, 552842, 552868, 552869, 552912, 552921, 552953, 552964, 553015, 553016, 553057, 553058, 553071, 553072, 553074, 553107, 553150, 553161, 553162, 553163, 553176, 553177, 553178, 553181, 553182, 553186, 553191, 553192, 553205, 553206, 553211, 553212, 553218, 553219, 553221, 553223, 553274, 553286, 553289, 553292, 553293, 553296, 553299, 553307, 553310, 553327, 553359, 553360, 553364, 553442, 553443, 553449, 553473, 553474, 553499, 553500, 553503, 553535, 553562, 553564, 553565, 553587, 553589, 553590, 553591, 553592, 553596, 553600, 553640, 553642, 553650, 553654, 553683, 553693, 553694, 553730, 553768, 553772, 553832, 553833, 553851, 553855, 553861, 553862, 553865, 553874, 553875, 553879, 553880, 553882, 553898, 553903, 553916, 553919, 553958, 553959, 553967, 553972, 553973, 553974, 553978, 553988, 553990, 554005, 554012, 554014, 554025, 554032, 554034, 554093, 554123, 554195, 554199, 554200, 554203, 554214, 554217, 554218, 554219, 554235, 554248, 554260, 554272, 554273, 554274, 554303, 554315, 554336, 554340, 554345, 554347, 554353, 554372, 554378, 554379, 554380, 554381, 554407, 554420, 554421, 554428, 554429, 554430, 554432, 554433, 554472, 554473, 554474, 554475, 554476, 554500, 554501, 554502, 554505, 554543, 554552, 554553, 554570, 554588, 554611, 554621, 554636, 554637, 554638, 554661, 554663, 554667, 554679, 554681, 554688, 554724, 554726, 554736, 554741, 554742, 554748, 554761, 554778, 554781, 554782, 554789, 554799, 554812, 554817, 554837, 554838, 554839, 554841, 554849, 554859, 554864, 554870, 554871, 554883, 554889, 554891, 554892, 554893, 554894, 554895, 554925, 554949, 554959, 554999, 555002, 555003, 555005, 555009, 555019, 555023, 555024, 555025, 555036, 555047, 555054, 555113, 555132, 555133, 555134, 555135, 555142, 555148, 555151, 555155, 555156, 555157, 555168, 555169, 555172, 555181, 555185, 555217, 555237, 555275, 555301, 555319, 555326, 555331, 555342, 555353, 555354, 555371, 555379, 555391, 555394, 555400, 555410, 555411, 555443, 555469, 555479, 555494, 555495, 555499, 555500, 555501, 555502, 555523, 555532, 555533, 555573, 555600, 555601, 555602, 555604, 555606, 555635, 555645, 555646, 555648, 555658, 555682, 555692, 555693, 555695, 555696, 555704, 555727, 555734, 555735, 555746, 555783, 555793, 555824, 555967, 555978, 556006, 556015, 556022, 556023, 556024, 556026, 556045, 556051, 556052, 556057, 556067, 556075, 556081, 556082, 556083, 556100, 556125, 556126, 556130, 556137, 556138, 556145, 556160, 556162, 556165, 556180, 556182, 556183, 556193, 556199, 556204, 556205, 556206, 556207, 556220, 556221, 556222, 556223, 556239, 556254, 556255, 556265, 556266, 556283, 556320, 556335, 556382, 556459, 556461, 556462, 556473, 556474, 556481, 556501, 556510, 556518, 556528, 556529, 556532, 556536, 556540, 556542, 556544, 556545, 556546, 556555, 556562, 556563, 556564, 556570, 556578, 556588, 556614, 556615, 556623, 556628, 556645, 556646, 556660, 556680, 556702, 556713, 556777, 556802, 556809, 556818, 556825, 556838, 556841, 556845, 556849, 556853, 556854, 556865, 556866, 556887, 556889, 556920, 556935, 556942, 556950, 556958, 556985, 556996, 556997, 556998, 557017, 557019, 557020, 557035, 557036, 557047, 557058, 557062, 557146, 557148, 557149, 557184, 557195, 557196, 557199, 557210, 557213, 557220, 557222, 557229, 557242, 557247, 557250, 557252, 557254, 557255, 557273, 557274, 557281, 557282, 557284, 557408, 557440, 557441, 557442, 557443, 557444, 557445, 557449, 557455, 557463, 557487, 557489, 557490, 557499, 557506, 557521, 557528, 557530, 557531, 557564, 557565, 557566, 557570, 557582, 557587, 557588, 557589, 557591, 557592, 557593, 557596, 557614, 557615, 557617, 557635, 557636, 557637, 557642, 557665, 557690, 557708, 557709, 557710, 557711, 557712, 557914, 557915, 558004, 558228, 558229, 558230, 558231, 558232, 558235, 558236, 558243, 558246, 558247, 558248, 558249, 558250, 558259, 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43128864, 43164321, 43171778, 43171779, 43198691, 43207053, 43209156, 43209392, 43350703, 43525480, 43569447, 43592314, 43681994, 43689105, 43706191, 44354078, 44644242, 44908585, 45378574, 49062534, and 49336814.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Philips Call Center
800-722-9377
Manufacturer Reason
for Recall
Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action On 10/04/2008, Philips began sending the URGENT-Device Correction BV Pulsera R2.2 and Endura R2.2 letters to their customers. On 09/03/2008, the firm issued the Field Change Order (FCO) 71800024 and the firm's representative will replace the stand-trolley cable free of charge. Customers should contact Philips Call Center at 1-800-722-9377, #5, #2, and reference "FCO 71800024" with any questions.
Quantity in Commerce 1331 units
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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