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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis

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  Class 2 Device Recall Axiom Artis see related information
Date Initiated by Firm September 09, 2010
Date Posted October 26, 2010
Recall Status1 Terminated 3 on September 29, 2012
Recall Number Z-0144-2011
Recall Event ID 56754
510(K)Number K021021  
Product Classification System, x-ray, angiographic - Product Code IZI
Product AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755
Angiographic X-ray System
Code Information Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755. Mulitple Serial Numbers per Distribution Listing
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Service
610-219-6300
Manufacturer Reason
for Recall		 Sporadic system crash while Perivision is performed.
FDA Determined
Cause 2		 Software design
Action Siemens issued an Urgent Field Safety Notice to all customers. The letter informed customers of the potential issues and provided additional information on the implemented resolution. To resolve the problem, a system update was to be installed on each affected system under Update Instructions AX054/10/S. For questions phone (610) 448-3237.
Quantity in Commerce 286 units
Distribution USA - Nationwide Distribution
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 SOLUTIONS USA, INC.
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