Class 2 Device Recall Axiom Artis System

• Date Initiated by Firm: May 28, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on August 25, 2004
• Recall Number: Z-0848-04
• Recall Event ID: 26598
• 510(K)Number: K010721
• Product Classification: System, X-Ray, Angiographic - Product Code IZI
• Product: Axiom Artis System
• Code Information: Part numbers 5904433, 5904649, 5904466, 5904441, 5904656, and 7007755. Serial numbers 10070, 10075, 10076, 10101, 10138, 10148, 10240, 10241, 10248, 10251, 10255, 10257, 10261, 10263, 10266, 14068, 20015, 20129, 20136, 25092, 25112, 25134, 25135, 25148, 25156, 25157, 25159, 25160, 25163, 25169, 25170, 28008, 28015, 28019, 28046, 28047, 28049, 28053, 28058, 28059, 28061, 32004, 32013, 32017, and 32019.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Parkway; Malvern PA 19355
• For Additional Information Contact: Roland Richter; 610-448-1777
• Manufacturer Reason for Recall: patient images misidentified
• FDA Determined Cause: Other
• Action: The recalling firm issued recall letters dated 5/28/03 to their accounts informing them of the problem.
• Quantity in Commerce: 46 units
• Distribution: The products were shipped to medical facilities nationwide.
• 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