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Class 2 Device Recall Axiom Artis dMP |
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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
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Product Classification |
Angiography X-Ray - Product Code IZI
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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
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For Additional Information Contact |
Michael Van Ryn 610-448-4500
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Manufacturer Reason for Recall |
Incorrect contour finding: Image may be calibrated to the wrong size catheter.
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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
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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 and Original Applicant = SIEMENS MEDICAL CORP.
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