FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat panel/digital imager). Model number 10252047. Universal fluoroscopic x-ray diagnostic system.
- Recall number
- Z-0326-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Status
- Terminated
- Initiated
- 2008-09-19
- Posted
- 2008-11-28
- Terminated
- 2009-09-23
- 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
- 3 units
- Distribution
- Nationwide Distribution --- including states of KY, NJ and PA.
- Lot, serial or model codes
- Serial numbers 10017, 10044, and 10049
- 510(k) numbers
- ["K062623"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28