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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Luminos dRF

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  Class 2 Device Recall Axiom Luminos dRF see related information
Date Initiated by Firm September 19, 2008
Date Posted November 28, 2008
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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