Class 2 Device Recall Axiom Artis

• Date Initiated by Firm: September 09, 2010
• Date Posted: October 26, 2010
• Recall Status: Terminated 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: 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