Z-0578-2007

AXIOM Artis MP, Angiographic x-ray system, model number 5904466

Name: Z-0578-2007 AXIOM Artis MP, Angiographic x-ray system, model number 5904466
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-01-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-01-31 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis MP, Angiographic x-ray system, model number 5904466 on 2007-01-31. The reason FDA records is "C-arm gantry could rapidly descend without command during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0578-2007
Status: Terminated
Initiated: 2007-01-31
Posted: 2007-03-08
Terminated: 2009-05-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis MP, Angiographic x-ray system, model number 5904466
Product code: IZI System, X-Ray, Angiographic
Reason for recall: C-arm gantry could rapidly descend without command during use.
FDA root cause: Other
Action: In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary.
Quantity in commerce: 62 units
Distribution: The products were shipped to medical facilities nationwide.
Product codes and lots: Model number number 5904466 - serial numbers: 20003, 20015, 20016, 20033, 20037, 20050, 20053, 20056, 20074, 20076, 20081, 20082, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20158, 20165, 20170, 20171, 20172, 20175, 20178, 20179, 20180, 20181, 20182, 20183, 20185, 20188, 20196, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, and 20303.

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)