Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat panel/digital imager). Model number 10252047. Universal
FDA device recall Z-0326-2009 · posted 2008-11-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure.
- Action taken
- 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
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 3 units
- Distribution
- Nationwide Distribution --- including states of KY, NJ and PA.
- Date initiated
- 2008-09-19
- Date posted
- 2008-11-28
- Date terminated
- 2009-09-23
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM LUMINOS DRF (K062623) | Siemens Medical Solutions USA, Inc. | 2007-08-22 |