| Class 2 Device Recall Allura XPER FD20/10 | |
Date Initiated by Firm | December 10, 2008 |
Date Posted | September 24, 2009 |
Recall Status1 |
Terminated 3 on August 17, 2012 |
Recall Number | Z-0348-2009 |
Recall Event ID |
50742 |
510(K)Number | K033737 K984545 |
Product Classification |
Angiographic X-Ray System - Product Code IZI
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Product | Allura XPER FD20/10 |
Code Information |
FCO 72200122 and 72200123 for the 1st phase 72200133 for the 2nd phase Equipment #'s 548432, 549242, 555356, 41443586, 41443727, 41443765, 41443909, 41444645, 41444752, 41444816, 41455925, 41455953, 42046093, 41445118
547914, 552599, 41455933, 504674, 534156, 538095, 538099, 538481, 539213, 540461, 541276, 542963, 543690, 543953, 544306, 544543, 544635, 544656, 544668, 544844, 545518, 545583, 545882, 546119, 546149, 546906, 547215, 547431, 547642, 547715, 548005, 548020, 548036, 548082, 548383, 548618, 549202, 549370, 550198, 550691, 550758, 550812, 550935, 552355, 552639, 553685, 553699, 553766, 558604, and 41444689. Additional Equipment #s from Phase 2 - 85130, 85634, 86450, 86584, 86985, 87317, 87359, 100812, 102908, 102937, 102974, 103381, 103722, 104341, 558945, 41443627, 41445615, 41445628, 41446230, 41446773, 41455944, 41793290, 41796154, 42067824, 42479274, 42508759, 42735090, 42891020, 42891095, 43058934, 43315510, 43436747, 43443622, 43635004, 43670742, 44616211, and 44735751. |
Recalling Firm/ Manufacturer |
Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell WA 98021-8431
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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 |
Action | An 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 Commerce | 101 units |
Distribution | Worldwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = IZI
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