Z-0818-05

Axiom Artis MP X-Ray System

Name: Z-0818-05 Axiom Artis MP X-Ray System
Creator: Siemens Medical Solutions USA, Inc
Published: 2005-04-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2005-04-01 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Artis MP X-Ray System on 2005-04-01. The reason FDA records is "potential problem with the fluoroscopy switch on the power grip". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0818-05
Status: Terminated
Initiated: 2005-04-01
Posted: 2005-05-11
Terminated: 2005-08-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Artis MP X-Ray System
Product code: IZI System, X-Ray, Angiographic
Reason for recall: potential problem with the fluoroscopy switch on the power grip
FDA root cause: Other
Action: The recalling firm''s Customer Service Engineers are visiting each account to correct/replace the Power Grip button.
Quantity in commerce: 21 units
Distribution: The products were shipped to hospitals in AL, AZ, DC, DE, IA, MI, NC, NE, PA, RI, TX, WA, and WI.
Product codes and lots: Serial numbers 10, 1021, 1025, 1026, 1027, 1043, 1044, 1048, 1050, 1052, 1056, 1065, 1067, 1069, 1080, 1082, 1083, 1085, 1087, 1089, and 1097.

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)