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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis dBA

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  Class 2 Device Recall Axiom Artis dBA 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-0124-2009
Recall Event ID 49584
510(K)Number K010721  K021021  
Product Classification Angiography X-Ray - Product Code IZI
Product Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357.
Code Information Model number 7555357. Serial numbers: 53002, 53007, 53008, 53027, 53028, 53030, 53031, 53032, 53046, 53059, 53079, 53089, 53090, 53091, 53092, 53105, 53106, 53112, 53122, 53125, 53127, 53129, 53134, 53137, 53148, 53151, 53157, 53158, 53163, 53167, 53168, 53169, 53170, 53180, 53182, 53183, 53184, 53185, 53187, 53188, 53189, 53190, 53191, 53192, 53193, 53195, 53196, 53197, 53199, 53200, 53201, 53202, 53203, 53204, 53205, 53206, 53207, 53208, 53209, 53210, 53211, 53212, 53213, 53215, 53216, 53217, 53218, 53219, 53220, 53221, 53222, 53223, 53224, 53225, 53226, 53227, 53228, 53229, 53231, 53232, 53233, 53234, 53235, 53237, 53238, 53239, 53240, 53706, 53707, 53708, 53709, 53710, and 53711.
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 93 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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