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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis dFCM

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 Class 2 Device Recall Axiom Artis dFCMsee related information
Date Initiated by FirmSeptember 02, 2008
Date PostedNovember 25, 2008
Recall Status1 Terminated 3 on October 05, 2009
Recall NumberZ-0125-2009
Recall Event ID 49584
510(K)NumberK010721 K021021 
Product Classification Angiography X-Ray - Product Code IZI
ProductAxiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System, Model number 7727717.
Code Information Model number 7727717. Serial numbers: 40000, 40061, 40062, 40063, 40064, 40065, 40066, 40067, 40069, 40070, and 40071
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 Commerce11 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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