Z-0144-2011

AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466...

Name: Z-0144-2011 AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466...
Creator: Siemens Medical Solutions USA, Inc
Published: 2010-09-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-09-09 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic... on 2010-09-09. The reason FDA records is "Sporadic system crash while Perivision is performed". 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-0144-2011
Status: Terminated
Initiated: 2010-09-09
Posted: 2010-10-26
Terminated: 2012-09-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic X-ray System
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Sporadic system crash while Perivision is performed.
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued an Urgent Field Safety Notice to all customers. The letter informed customers of the potential issues and provided additional information on the implemented resolution. To resolve the problem, a system update was to be installed on each affected system under Update Instructions AX054/10/S. For questions phone (610) 448-3237.
Quantity in commerce: 286 units
Distribution: USA - Nationwide Distribution
Product codes and lots: Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755. Mulitple Serial Numbers per Distribution Listing

Product code IZI

K021021Class IIModular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. / cleared 2002-06-06

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)