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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Medical Axiom Artis System

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  Class 2 Device Recall Siemens Medical Axiom Artis System see related information
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
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 = SIEMENS MEDICAL CORP.
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