Z-0163-2009

Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803

Name: Z-0163-2009 Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-08-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-08-25 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803 on 2008-08-25. The reason FDA records is "Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope". 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-0163-2009
Status: Terminated
Initiated: 2008-08-25
Posted: 2008-10-20
Terminated: 2008-10-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems.
Quantity in commerce: 7 units
Distribution: Nationwide distribution including states of CA, IN, KY, UT, VA and WI.
Product codes and lots: Serial numbers: 1059, 1078, 1083, 1088, 1093, 1109, and 1135.

Product code KPR

K013826Class IIAxiom Aristos Fx (Multi Purpose Radiography System)Siemens Medical Systems, Inc. / cleared 2002-02-01

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)