Z-0347-03

Axiom Artis System, X-ray, Angiographic

Name: Z-0347-03 Axiom Artis System, X-ray, Angiographic
Creator: Siemens Medical Systems Inc
Published: 2002-08-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2002-08-05 / Terminated

FDA source

Siemens Medical Systems Inc began a recall of Axiom Artis System, X-ray, Angiographic on 2002-08-05. The reason FDA records is "Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0347-03
Status: Terminated
Initiated: 2002-08-05
Posted: 2002-12-18
Terminated: 2004-10-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Artis System, X-ray, Angiographic
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked.
FDA root cause: Other
Action: A Safety Advisory Letter was sent 7/23/2002 by Siemens Medical. The letter advised the technicians of the problem and Siemens would be coming out to do the software modificaitons.
Quantity in commerce: 134
Distribution: The device was distributed to Hospitals nationwide.
Product codes and lots: Axiom Artis System: Axiom Artis FC Model #5904433 --all serial #s Axiom Artis FA Model #5904441 --all serial #s Axiom Artis BC Model #5904649 --all serial #s Axiom Artis BA Model #5904656 --all serial #s Axiom Artis MP Model #5904466 -- all serial #s

Product code IZI

K010721Class IIAxiom Artis Modular Angiography SystemSiemens Medical Corp. / cleared 2001-03-30

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)