Z-0327-2009

Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager). Model number...

Name: Z-0327-2009 Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager). Model number...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-09-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-09-19 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager). Model number 10252048. Universal fluoroscopic x-ray diagnostic... on 2008-09-19. The reason FDA records is "Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0327-2009
Status: Terminated
Initiated: 2008-09-19
Posted: 2008-11-28
Terminated: 2009-09-23
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure.
Root cause tag: manufacturing process
FDA 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 in commerce: 1 unit
Distribution: Nationwide Distribution --- including states of KY, NJ and PA.
Product codes and lots: Serial number 10046

Product code MQB

K062623Class IIAxiom Luminos DrfSiemens Medical Solutions USA, Inc. / cleared 2007-08-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)