Class 2 Device Recall Axiom Artis MP XRay System

• Date Initiated by Firm: April 01, 2005
• Date Posted: May 11, 2005
• Recall Status: Terminated on August 18, 2005
• Recall Number: Z-0818-05
• Recall Event ID: 31647
• 510(K)Number: K010721
• Product Classification: System, X-Ray, Angiographic - Product Code IZI
• Product: Axiom Artis MP X-Ray System
• Code Information: Serial numbers 10, 1021, 1025, 1026, 1027, 1043, 1044, 1048, 1050, 1052, 1056, 1065, 1067, 1069, 1080, 1082, 1083, 1085, 1087, 1089, and 1097.
• 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: potential problem with the fluoroscopy switch on the power grip
• FDA Determined Cause: Other
• Action: The recalling firm''s Customer Service Engineers are visiting each account to correct/replace the Power Grip button.
• Quantity in Commerce: 21 units
• Distribution: The products were shipped to hospitals in AL, AZ, DC, DE, IA, MI, NC, NE, PA, RI, TX, WA, and WI.
• 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