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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis

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 Class 2 Recall
Axiom Artis
see related information
Date Posted October 26, 2010
Recall Status1 Terminated on September 29, 2012
Recall Number Z-0144-2011
Recall Event ID 56754
Premarket Notification
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, Pennsylvania 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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