Date Initiated by Firm | August 05, 2002 |
Date Posted | December 18, 2002 |
Recall Status1 |
Terminated 3 on October 25, 2004 |
Recall Number | Z-0347-03 |
Recall Event ID |
25073 |
510(K)Number | K010721 |
Product Classification |
System, X-Ray, Angiographic - Product Code IZI
|
Product | Axiom Artis System, X-ray, Angiographic |
Code Information |
Axiom Artis System: Axiom Artis FC Model #5904433 --all serial #s Axiom Artis FA Model #5904441 --all serial #s Axiom Artis BC Model #5904649 --all serial #s Axiom Artis BA Model #5904656 --all serial #s Axiom Artis MP Model #5904466 -- all serial #s |
Recalling Firm/ Manufacturer |
Siemens Medical Systems Inc 186 Wood Ave So Iselin NJ 08830
|
For Additional Information Contact | Roland Richter 732-321-4835 |
Manufacturer Reason for Recall | Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked. |
FDA Determined Cause 2 | Other |
Action | A Safety Advisory Letter was sent 7/23/2002 by Siemens Medical. The letter advised the technicians of the problem and Siemens would be coming out to do the software modificaitons. |
Quantity in Commerce | 134 |
Distribution | The device was distributed to Hospitals nationwide. |
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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