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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis dFA

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 Class 2 Device Recall Axiom Artis dFAsee related information
Date Initiated by FirmSeptember 02, 2008
Date PostedNovember 25, 2008
Recall Status1 Terminated 3 on October 05, 2009
Recall NumberZ-0126-2009
Recall Event ID 49584
510(K)NumberK010721 K021021 
Product Classification Angiography X-Ray - Product Code IZI
ProductAxiom Artis dFA, Axiom Artis Modular Angiography X-Ray System, Model number 7555373.
Code Information Model number 7555373. Serial numbers: 50080, 50135, 50137, 50138, 50139, 50140, 50141, 50142, 50143, 50144, 50145, 50146, 50147, 501 48, 50149, 50151, 50152, 50153, 50154, 50155, 50156, 50157, 50158, 50159, 50160, 50161, 50163, 50164, 50165, 50166, 50167, 50169, 50170, 50171, 50172, 51708, 51709, 51710, 51711, 51712, and 51713.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information ContactMichael Van Ryn
610-448-4500
Manufacturer Reason
for Recall		Incorrect contour finding: Image may be calibrated to the wrong size catheter.
FDA Determined
Cause 2		Software design
ActionSiemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.
Quantity in Commerce41 units
DistributionNationwide.
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
510(K)s with Product Code = IZI
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