Z-0314-2009

AXIOM Artis System dFA using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a...

Name: Z-0314-2009 AXIOM Artis System dFA using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a...
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: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis System dFA using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane... on 2008-08-25. The reason FDA records is "System may switch to emergency fluoroscopy mode". 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-0314-2009
Status: Terminated
Initiated: 2008-08-25
Posted: 2008-12-09
Terminated: 2010-01-26
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis System dFA using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: System may switch to emergency fluoroscopy mode.
Root cause tag: software
FDA root cause: Software design
Action: A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue.
Quantity in commerce: 2 units
Distribution: Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY.
Product codes and lots: Model number 7555373. Serial numbers: 50176 and 51707

Product code IZI

K052202Class IIAxiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. / cleared 2006-03-07

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)