Z-0717-2011

Axiom Luminos dRF

Name: Z-0717-2011 Axiom Luminos dRF
Creator: Siemens Medical Solutions USA, Inc
Published: 2010-10-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-10-25 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager) on 2010-10-25. The reason FDA records is "patient leg can be pinched". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0717-2011
Status: Terminated
Initiated: 2010-10-25
Posted: 2010-12-17
Terminated: 2012-09-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager)
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: patient leg can be pinched
FDA root cause: Other
Action: SIEMENS sent a Customer Safety Advisory Notice dated October 25, 2010, to affected customers via Update Instructions AX072/10/S. The notice described the issue and the actions to be taken by customers. The customers were instructed to retain the annex together with their operating instructions and bring the hazard to the attention of their employees; inform all users and other persons of this notice; if they sold the device, forward this notice and attachment to the new owners of the device and provide SIEMENS with details of the new owners. If you have any questions, please contact +1-888-826-9702.
Quantity in commerce: 24 units
Distribution: Nationwide distribution: CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NJ, and NY.
Product codes and lots: Model number 10094200. Serial numbrs: 1148, 1149, 1182, 1191, 1194, 1221, 1224, 1250, 1265, 1316, 1327, 1358, 1410, 1419, 1443, 2022, 2024, 2025, 2049, 2054, 2069, 2070, 2076, and 2092.

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)