Class 2 Device Recall Axiom Aristos FX

• Date Initiated by Firm: August 25, 2008
• Date Posted: October 20, 2008
• Recall Status: Terminated on October 20, 2008
• Recall Number: Z-0163-2009
• Recall Event ID: 49567
• 510(K)Number: K013826
• Product Classification: AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTE - Product Code KPR
• Product: Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.
• Code Information: Serial numbers: 1059, 1078, 1083, 1088, 1093, 1109, and 1135.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Michael Van Ryn; 610-448-4500
• Manufacturer Reason for Recall: Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.
• FDA Determined Cause: Equipment maintenance
• Action: Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems.
• Quantity in Commerce: 7 units
• Distribution: Nationwide distribution including states of CA, IN, KY, UT, VA 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 = KPR