Class 2 Device Recall Axiom Luminos dRF

• Date Initiated by Firm: September 19, 2008
• Date Posted: November 28, 2008
• Recall Status: Terminated on September 23, 2009
• Recall Number: Z-0327-2009
• Recall Event ID: 50123
• 510(K)Number: K062623
• Product Classification: Solid State X-Ray Imager - Product Code MQB
• Product: Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager). Model number 10252048. Universal fluoroscopic x-ray diagnostic system.
• Code Information: Serial number 10046
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Michael Van Ryn; 610-448-4634
• Manufacturer Reason for Recall: Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm issued Update Instruction AX042/08/S dated August 2008, to affected customers. This Update instruction provided Siemens service engineers with instructions for the replacement of the joystick module at each facility.
• Quantity in Commerce: 1 unit
• Distribution: Nationwide Distribution --- including states of KY, NJ 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 = MQB