Class 2 Device Recall Axiom Aristos XRay System

• Date Initiated by Firm: April 19, 2003
• Date Posted: July 08, 2003
• Recall Status: Terminated on August 25, 2004
• Recall Number: Z-0984-03
• Recall Event ID: 26596
• 510(K)Number: K013826
• Product Classification: System, X-Ray, Stationary - Product Code KPR
• Product: Axiom Aristos X-Ray System.
• Code Information: part numbers 5895003 and 7414803. serial numbers 01001, 01170, 01219, 01221, and 01030.
• 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: software malfunction. May indicate that the image is flipped when it is not.
• FDA Determined Cause: Other
• Action: The recalling firm issued recall letters dated 4/19/03 to their accounts along with instructions for handling images that have already been archived.
• Quantity in Commerce: 5 units
• Distribution: The units 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 = KPR