Z-0989-05

Axiom Aristos MX/VX. Model number 58 95 003

Name: Z-0989-05 Axiom Aristos MX/VX. Model number 58 95 003
Creator: Siemens Medical Solutions USA, Inc
Published: 2005-06-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2005-06-10 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Aristos MX/VX. Model number 58 95 003 on 2005-06-10. The reason FDA records is "potential issue (system may lock up) when repeating patient registrations". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0989-05
Status: Terminated
Initiated: 2005-06-10
Posted: 2005-07-13
Terminated: 2006-08-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Aristos MX/VX. Model number 58 95 003
Product code: KPR System, X-Ray, Stationary
Reason for recall: potential issue (system may lock up) when repeating patient registrations
FDA root cause: Other
Action: The recalling firm issed a Customer Advisory Letter via certified mail to their cutomers informing them of the problem and information for the workaround to prevent problems for occurring until the software is upgraded.
Quantity in commerce: 72 units
Distribution: Nationwide. The products were shipped to hospitals in AZ, CA, CO, FL, GA, IL, IN, KS, KY, ME, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA, WA, and WI.
Product codes and lots: Serial numbers 1001 through 1017, 1019 through 1071, and 1073 through 1469

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)