Z-1383-2012

Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)

Name: Z-1383-2012 Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-02-16
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-02-16 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager) on 2012-02-16. The reason FDA records is "During regular product monitoring, Siemens became aware of a potential issue with the AXIOM Luminos dRF. Firm became aware of a potential issue with torque wrenches - during a regular scheduled calibration of the...". 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-1383-2012
Status: Terminated
Initiated: 2012-02-16
Posted: 2012-04-09
Terminated: 2014-11-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: During regular product monitoring, Siemens became aware of a potential issue with the AXIOM Luminos dRF. Firm became aware of a potential issue with torque wrenches - during a regular scheduled calibration of the wrench, it was discovered that the wrench was out of the specification. The wrench was over-torquing approximately 21% for low-end readings (50 ftlbs) and 9% for high-end readings (250
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens initiated a recall/correction on February 16, 2012 by issuing Update Instruction XP056/11/S to the affected customers. All screws on the unit support on AXIOM Luminos dRF units will be replaced by a Siemens service engineer. For information regarding this recall call 610-219-4834.
Quantity in commerce: 2
Distribution: Nationwide Distribution including California
Product codes and lots: Model number 10094200, serial numbers 3019 and 1358

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)