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U.S. Department of Health and Human Services

Class 2 Device Recall Allura XPER 10/10

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 Class 2 Device Recall Allura XPER 10/10see related information
Date Initiated by FirmDecember 10, 2008
Date PostedSeptember 24, 2009
Recall Status1 Terminated 3 on August 17, 2012
Recall NumberZ-0344-2009
Recall Event ID 50742
510(K)NumberK031333 K984545 
Product Classification Angiographic X-Ray System - Product Code IZI
ProductAllura XPER 10/10
Code Information FCO 72200124 and 72200125 for 1st phase FCO 72200133 for 2nd phase Equipment #'s: 103281, 103283, 505903, 506119, 530653, 532614, 533397, 536028, 536031, 536034, 536035, 536037, 536042, 536171, 536715, 536789, 536899, 537631, 537804, 538028, 538157, 538387, 538409, 538514, 538516, 539326, 539628, 540184, 540237, 541577, 541589, 541590, 542413, 542557, 542714, 543200, 543289, 543411, 543879, 543989, 544395, 544433, 545025, 545396, 545604, 545753, 545884, 545997, 546013, 546569, 547173, 547769, 547823, 547922, 548140, 548288, 549368, 549903, 551855, 554802, 554970, 555293, 555299, 555834, 41443647, 41443804, 41444647, 41444650, 41445448, 41445501, 41445538, 41455885, 41455897, 41455920, 41780160, 42057324, and 42064724.   Additional Equipment #s from phase 2- 10107, 101110, 101205, 557729, 557908, 41443609, 41445432, 41446024, 41446262, 41660520, 42046440, 42064058, 42394072, 42553772, 42625859, 42891704, 43043666, 43164789, 43173591, 43453735, 43848923, 43931292, 44028554, 44066424, 44193760, 44892370, and 47140511.
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact
425-487-7602
Manufacturer Reason
for Recall		Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionAn Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C
Quantity in Commerce104 units
DistributionWorldwide Distribution
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZI
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