Class 2 Device Recall AXIOM ARTIS MODULAR ANGIOGRAPHIC SYSTEM

• Date Initiated by Firm: August 25, 2008
• Date Posted: December 09, 2008
• Recall Status: Terminated on January 26, 2010
• Recall Number: Z-0315-2009
• Recall Event ID: 49569
• 510(K)Number: K052202
• Product Classification: Angiographic x-ray system - Product Code IZI
• Product: AXIOM Artis System dTC using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.
• Code Information: Model number 7413078. Serial numbers: 46130, 46150, and 46205.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Michael Van Ryn; 610-448-4500
• Manufacturer Reason for Recall: System may switch to emergency fluoroscopy mode.
• FDA Determined Cause: Software design
• Action: A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue.
• Quantity in Commerce: 3 units
• Distribution: Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY.
• 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