Class 2 Device Recall Axiom Artis BA or BC Biplane System

• Date Initiated by Firm: August 10, 2004
• Date Posted: September 14, 2004
• Recall Status: Terminated on January 25, 2005
• Recall Number: Z-1450-04
• Recall Event ID: 29919
• 510(K)Number: K010721
• Product Classification: System, X-Ray, Angiographic - Product Code IZI
• Product: Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 656
• Code Information: Serial numbers: 28000, and 28002-28118
• 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: Opacification Function of device may incorrectly merge images
• FDA Determined Cause: Other
• Action: The recalling firm has issued a Customer Safety Advisory letter with Update Instructions AX067/04/S to the affected customers via certified mail on 8/12/04. The recalling firm is preparing a software update to correct the problem.
• Quantity in Commerce: 34 units
• Distribution: The product was shipped to 64 medical facilities nationwide and 2 government accounts in CA and PA.
• 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