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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis dBC

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  Class 2 Device Recall Axiom Artis dBC 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-0128-2009
Recall Event ID 49584
510(K)Number K010721  K021021  
Product Classification Angiography X-Ray - Product Code IZI
Product Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392.
Code Information Model number 7728392. Serial numbers: 44075, 44077, 44084, 44240, 44262, 44265, 44267, 44268, 44269, 44270, 44271, 44272, 44273, 44274, 44275, 44276, 44277, 44278, 44279, 44280, 44281, 44282, 44283, 44284, 44285, 44286, 44287, 44288, 44289, 44290, 44291, 44292, 44293, 44294, 44295, 44296, 44298, 44299, 44300, 44302, 44303, 44304, 44305, 44306, 44307, and 44308.
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 46 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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