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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 Device 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
510(K)Number K010435 
Product Classification Mobile X-ray system - 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,
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
425-487-7602
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
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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