| Class 2 Device Recall OminDiagnost Eleva | |
Date Initiated by Firm | December 10, 2008 |
Date Posted | September 24, 2009 |
Recall Status1 |
Terminated 3 on August 17, 2012 |
Recall Number | Z-0352-2009 |
Recall Event ID |
50742 |
510(K)Number | K032046 |
Product Classification |
Angiographic X-Ray System - Product Code JAA
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Product | OminDiagnost Eleva |
Code Information |
FCO 70800085 Equipment #'s 102666, 103056, 104083, 104136, 104530, 104838, 105194, 105394, 504340, 504341, 505039, 505345, 505346, 506236, 506247, 519141, 519142, 519574, 519952, 520020, 520046, 521113, 521977, 522220, 530589, 530777, 532087, 532140, 532151, 532213, 532703, 533112, 533314, 533471, 533473, 533559, 534247, 535257, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 539106, 539598, 539990, 540252, 541263, 541490, 543272, 544059, 545014, 545841, 546031, 547017, 547348, 549798, 553676, 558404, 42036161, 42383151, 43180366, 43180367, and 43680651, |
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 | 69 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 = JAA
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