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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 12, 2005
Date Posted November 29, 2005
Recall Status1 Terminated 3 on March 09, 2011
Recall Number Z-0207-06
Recall Event ID 33873
510(K)Number K925302  K984545  K002016  K020055  K031333  
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.
Code Information Site numbers: 530664, 519535, 532292, 533551, 538806, 532150, 504797, 504807, 504730, 533418, 536796, 534743, 532178, 520525, 504798, 504806, 534681, 534731, 536899, 522418, 536641, 533897, 534221, 505651, 530391, 530390, 532074, 535931, 536646, 539094, 522162, 536007, 535979, 536138, 504659, 536136, 540048, 539628, 519533, 535946, 533796, 538234, 504666, 531830, 505861, 505860, 540237, 506564, 536592, 532532, 536067, 505587, 535274, 532227, 535278, 520309, 537386, 537630, 506148, 530666, 521320, 521892, 530667, 533763, 530392, 533762, 538902, 531837, 531834, 520814, 537357, 521548, 534218, 521589, 105784, 536433, 536234, 530669, 532244, 520524, 521463, 535367, 521890, 520755, 520523, 532245, 535285, 534678, 536717, 532264, 534217, 506621, 530370, 538369, 534682, 530368, 534215, 530460, 505805, 534810, 535951, 538406, 538744, 538476, 538903, 537065, 534477, 534479, 536163, 534478, 536014, 104925, 534476, 532294, 522253, 520236, 519812, 504750, 536154, 536155, 530715, 535728, 534639, 535727, 534638, 538482, 538512, 506049, 536777, 104149, 531948, 519594, 519771, 531760, 535793, 533283, 519677, 533284, 538514, 506658, 533278, 533282, 506657, 533287, 533286, 533285, 534232, 506654, 522245, 506047, 506170, 532533, 532614, 520809, 532616, 506178, 532535, 535813, 532534, 532617, 532613, 534856, 532615, 532246, 521763, 539204, 522138, 520632, 535342, 531806, 504747, 531805, 521545, 521537, 533738, 532799, 532215, 522038, 521315, 520630, 104954, 535566, 104958, 531961, 538102, 538538, 103711, 535439, 104952, 537020, 534798, 521314, 520631, 104956, 104957, 104955, 522440, 506322, 105656, 105655, 537985, 104075, 531944, 521312, 534796, 535424, 540421, 105670, 522135, 531943, 521311, 505759, 104514, 104515, 521675, 104670, 531945, 535376, 536901, 521802, 520251, 506616, 506403, 531942, 530584, 531957, 531817, 531813, 506785, 538464, 521318, 522293, 504940, 538516, 534876, 521512, 532446, 531946, 505925, 533343, 520491, 534246, 531949, 532445, 505968, 536178, 538269, 535667, 531951, 536715, 536090, 535702, 534452, 534255, 505707, 522247, 522243, 520481, 522250, 505679, 531931, 506476, 505106, 505668, 532249, 536789, 505107, 537804, 535927, 531753, 535615, 534813, 531752, 538485, 538486, 538228, 521650, 520977, 538466, 534233, 105674, 537024, 521711, 534724, 533967, 105940, 505486, 104642, 539220, 105390, 519901, 521820, 519213, 538028, 533476, 534420, 534158, 520783, 530421, 531728, 537698, 520793, 104890, 532080, 533966, 536028, 533955, 536034, 536031, 536042, 532077, 536035, 533956, 536037, 534730, 533401, 105960, 538771, 534150, 519738, 534787, 534630, 520681, 500038, 534152, 506637, 535418, 520431, 520004, 504665, 520660, 519214, 521659, 535779, 105947, 535415, 535396, 519541, 521854, 520761, 536171, 103128, 506370, 105912, 519548, 534431, 538368, 520680, 534569, 506230, 105615, 506232, 536174, 519576, 536798, 534160, 536379, 534237, 519211, 520430, 540841, 539479, 539107, 506717, 538465, 536993, 537784, 535814, 505572, 521853, 500028, 500029, 522065, 520948, 520882, 506169, 519115, 532652, 522177, 532649, 537205, 505719, 504789, 534716, 504493, 504792, 532990, 535614, 534717, 506408, 519733, 534758, 534440, 519680, 534811, 540622, 522191, 534374, 535224, 522397, 506397, 519899, 538386, 519894, 105136, 533395, 505254, 505989, 540082, 500042, 519195, 105081, 105082, 105186, 533236, 537266, 519198, 535492, 520779, 533772, 532611, 533922, 537073, 531651, 532986, 532612, 522119, 532263, 535400, 522118, 105140, 105191, 505809, 533085, 533084, 103562, 537118, 506538, 105598, 102948, 103265, 534427, 531808, 103561, 531762, 540288, 537934, 538193, 538157, 506540, 506539, 532262, 520956, 103331, 530485, 505876, 103564, 539099, 104464, 533619, 103780, 102499, 540016, 537805, 102560, 538813, 105779, 521661, 533861, 103781, 535635, 522458, 535611, 533543, 519537, 532225, 519534, 504770, 537597, 538479, 534250, 539322, 521770, 521769, 105157, 505281, 521222, 535173, 534545, 534380, 538194, 535202, 537644, 534565, 533857, 536471, 535250, 536639, 534270, 534268, 536173, 537466, 534108, 521154, 534874.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall
Potential for high voltage exposure involving the injector interface connector of patient support tables.
FDA Determined
Cause 2
Other
Action On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.
Quantity in Commerce 529 units with MD6 tablets
Distribution Devices were distributed nationwide to hospitals/medical centers.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS
510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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