Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager). Model number 10252048. Universal fluoroscopic x-ray diagnostic system.
FDA Recall Z-0327-2009 · Posted 2008-11-28
Advertisement
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2008-09-19
Date Terminated2009-09-23
Product Quantity1 unit
Reason for Recall
Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution --- including states of KY, NJ and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement