Class 2 Device Recall Axiom Artis XRay System using software version VB11D or VB20B

• Date Initiated by Firm: April 11, 2005
• Date Posted: May 03, 2005
• Recall Status: Terminated on August 23, 2006
• Recall Number: Z-0796-05
• Recall Event ID: 31761
• 510(K)Number: K010721
• Product Classification: System, X-Ray, Angiographic - Product Code IZI
• Product: Axiom Artis X-Ray System using software version VB11D or VB20B
• Code Information: model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Roland Richter; 610-448-1777
• Manufacturer Reason for Recall: Live display in exam room may sporadically stop working although the display in the control room remains fully operational
• FDA Determined Cause: Other
• Action: The manufacturer provided a Customer Safety Advisory letter dated 3/24/05. The letter describes the problem and the interim work around. This letter was forward to the recalling firm''s direct accounts.
• Quantity in Commerce: 295 units
• Distribution: The product was shipped to hospitals in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA,WA,WI, and WV.
• 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