Z-0984-03

Axiom Aristos X-Ray System

Name: Z-0984-03 Axiom Aristos X-Ray System
Creator: Siemens Medical Solutions USA, Inc
Published: 2003-04-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-04-19 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Aristos X-Ray System on 2003-04-19. The reason FDA records is "software malfunction. May indicate that the image is flipped when it is not". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0984-03
Status: Terminated
Initiated: 2003-04-19
Posted: 2003-07-08
Terminated: 2004-08-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Aristos X-Ray System.
Product code: KPR System, X-Ray, Stationary
Reason for recall: software malfunction. May indicate that the image is flipped when it is not.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm issued recall letters dated 4/19/03 to their accounts along with instructions for handling images that have already been archived.
Quantity in commerce: 5 units
Distribution: The units were shipped to medical facilities nationwide.
Product codes and lots: part numbers 5895003 and 7414803. serial numbers 01001, 01170, 01219, 01221, and 01030.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)