Class 2 Device Recall Siemens AXIOM Aristos FX Plus

• Date Initiated by Firm: December 12, 2011
• Date Posted: January 25, 2012
• Recall Status: Terminated on January 14, 2014
• Recall Number: Z-0860-2012
• Recall Event ID: 60789
• 510(K)Number: K061054
• Product Classification: Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
• Product: Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system.
• Code Information: Serial number 1273
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Anastasia Mason; 610-219-4834
• Manufacturer Reason for Recall: Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type.
• FDA Determined Cause: Process control
• Action: Siemens Healthcare sent a "SAFETY ADVISORY NOTICE" dated December 12, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer. The firm prepared a modification, which will be provided to the affected customer under Update Instruction XP055/11/S. The firm will resolve this potential issue by preventively exchanging all bolts for the fixation of the X-ray tube holder of the concerned AXIOM Aristos FX Plus unit.
• Quantity in Commerce: 1
• Distribution: Product distributed in one hospital in California.
• 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 = MQB