—#74778

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.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K062623
Affected lot / code info: Serial number 10046

Why it was recalled

Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution --- including states of KY, NJ and PA.

Timeline

Recall initiated: 2008-09-19
Posted by FDA: 2008-11-28
Terminated: 2009-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74778. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.