Z-0483-2010

Axiom Artis MP, Model number 5904466 angiographic x-ray systems

Name: Z-0483-2010 Axiom Artis MP, Model number 5904466 angiographic x-ray systems
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-10-26
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-10-26 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Artis MP, Model number 5904466 angiographic x-ray systems on 2009-10-26. The reason FDA records is "c-arm may tilt". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0483-2010
Status: Terminated
Initiated: 2009-10-26
Posted: 2009-12-03
Terminated: 2010-01-26
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Artis MP, Model number 5904466 angiographic x-ray systems
Product code: IZI System, X-Ray, Angiographic
Reason for recall: c-arm may tilt
FDA root cause: Other
Action: The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons.
Quantity in commerce: 70 units
Distribution: Nationwide
Product codes and lots: Serial numbers: 20003, 20015, 20016, 20033, 20037, 20050, 20052, 20053, 20056, 20074, 20076, 20081, 20082, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20165, 20170, 20171, 20172, 20175, 20178, 20180, 20181, 20182, 20183, 20185, 20188, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, 20303, 20313, 20321, 20322, 20325, 20334, 20338, 20339, 20343, 20348, and 20363.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)