Z-0860-2012

Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system

Name: Z-0860-2012 Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-12-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-12-12 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system on 2011-12-12. The reason FDA records is "Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type". 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-0860-2012
Status: Terminated
Initiated: 2011-12-12
Posted: 2012-01-25
Terminated: 2014-01-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens Healthcare sent a "SAFETY ADVISORY NOTICE" dated December 12, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer. The firm prepared a modification, which will be provided to the affected customer under Update Instruction XP055/11/S. The firm will resolve this potential issue by preventively exchanging all bolts for the fixation of the X-ray tube holder of the concerned AXIOM Aristos FX Plus unit.
Quantity in commerce: 1
Distribution: Product distributed in one hospital in California.
Product codes and lots: Serial number 1273

Product code MQB

K061054Class IIAxiom Aristos Fx PlusSiemens Medical Solutions USA, Inc. / cleared 2006-05-09

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)