Z-1449-04

Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649

Name: Z-1449-04 Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649
Creator: Siemens Medical Solutions USA, Inc
Published: 2004-08-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-08-10 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649 on 2004-08-10. The reason FDA records is "Opacification Function of device may incorrectly merge images". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1449-04
Status: Terminated
Initiated: 2004-08-10
Posted: 2004-09-14
Terminated: 2005-01-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Opacification Function of device may incorrectly merge images
FDA root cause: Other
Action: The recalling firm has issued a Customer Safety Advisory letter with Update Instructions AX067/04/S to the affected customers via certified mail on 8/12/04. The recalling firm is preparing a software update to correct the problem.
Quantity in commerce: 37 units
Distribution: The product was shipped to 64 medical facilities nationwide and 2 government accounts in CA and PA.
Product codes and lots: Serial numbers: 14002-14004, 14006-14012, 14014, 14018, 14021, 14025, 14029, 14033, 14041-14042, 14044-14045, 14049, 14051, 14055, 14058, 14060-14065, 14064-14065, 14068, 14071, 14074-14075, 14080-14081, 14084-14088, and 14092

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)