Date Initiated by Firm | September 19, 2008 |
Date Posted | November 28, 2008 |
Recall Status1 |
Terminated 3 on September 23, 2009 |
Recall Number | Z-0326-2009 |
Recall Event ID |
50123 |
510(K)Number | K062623 |
Product Classification |
Solid State X-Ray Imager - Product Code MQB
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Product | Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat panel/digital imager). Model number 10252047.
Universal fluoroscopic x-ray diagnostic system. |
Code Information |
Serial numbers 10017, 10044, and 10049 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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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 | 3 units |
Distribution | Nationwide Distribution --- including states of KY, NJ and PA. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MQB
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