Recall Z-0327-2009 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Siemens Medical Solutions USA, Inc
Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager). Model number 10252048. Universal fluoroscopic x-ray diagnostic system.
| Date | Nov 28, 2008 (initiated Sep 19, 2008) |
| Status | Terminated |
| Reason | Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure. |
| Root 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 | 1 unit |
| Distribution | Nationwide Distribution --- including states of KY, NJ and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062623 | AXIOM LUMINOS DRF Siemens Medical Solutions USA, Inc., Aug 22, 2007 |