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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis dMP

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  Class 2 Device Recall Axiom Artis dMP see related information
Date Initiated by Firm September 02, 2008
Date Posted November 25, 2008
Recall Status1 Terminated 3 on October 05, 2009
Recall Number Z-0127-2009
Recall Event ID 49584
510(K)Number K010721  K021021  
Product Classification Angiography X-Ray - Product Code IZI
Product Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model number 7555365.
Code Information Model number 7555365. Serial numbers: 57001, 57002, 57093, 57103, 57119, 57122, 57132, 57133, 57134, 57135, 57136, 57137, 57139, 57140, 57141, 57143, 57144, 57145, 57146, 57147, 57148, 57149, 57150, 57151, 57152, 57153, 57154, 57156, 57157, 57158, 57159, 57160, 57161, 57162, 571 63, 57164, 57165, 57166, 57167, 57168, 57169, 57170, 57171, 57172, 57173, 57174, 57175, 57177, 57178, 57179, 57181, 57182, 57183, 57184, 57185, and 57186
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Michael 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
Action Siemens 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 Commerce 56 units
Distribution 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.
510(K)s with Product Code = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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