Z-0796-05

Axiom Artis X-Ray System using software version VB11D or VB20B

Name: Z-0796-05 Axiom Artis X-Ray System using software version VB11D or VB20B
Creator: Siemens Medical Solutions USA, Inc
Published: 2005-04-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2005-04-11 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Artis X-Ray System using software version VB11D or VB20B on 2005-04-11. The reason FDA records is "Live display in exam room may sporadically stop working although the display in the control room remains fully operational". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0796-05
Status: Terminated
Initiated: 2005-04-11
Posted: 2005-05-03
Terminated: 2006-08-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Artis X-Ray System using software version VB11D or VB20B
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Live display in exam room may sporadically stop working although the display in the control room remains fully operational
FDA root cause: Other
Action: The manufacturer provided a Customer Safety Advisory letter dated 3/24/05. The letter describes the problem and the interim work around. This letter was forward to the recalling firm''s direct accounts.
Quantity in commerce: 295 units
Distribution: The product was shipped to hospitals in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA,WA,WI, and WV.
Product codes and lots: model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350

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)