Z-1108-04

SIEMENS AXIOM Artis - AUTOMAP FUNCTION

Name: Z-1108-04 SIEMENS AXIOM Artis - AUTOMAP FUNCTION
Creator: Siemens Medical Solutions USA, Inc
Published: 2004-06-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-06-02 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of SIEMENS AXIOM Artis - AUTOMAP FUNCTION on 2004-06-02. The reason FDA records is "Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1108-04
Status: Terminated
Initiated: 2004-06-02
Posted: 2004-07-20
Terminated: 2004-10-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SIEMENS AXIOM Artis - AUTOMAP FUNCTION
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash.
FDA root cause: Other
Action: The recalling firm sent recall letter to their customers informing them of the software problem. The customers were informed that a Siemens Service Representative will visit each location to deactivate Module 2 of the AUTOMAP function per Update AX023/04S.
Quantity in commerce: 127 units
Distribution: The recalled product has been distributed throughout the United States, such as: AK, AL, AZ, CA, DC, FL, GA, IA, IL, IN, KY, LA, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI,
Product codes and lots: Model Numbers: AXIOM Artis FC 5904433 AXIOM Artis BC 5904649 AXIOM Artis MP 5904466 AXIOM Artis FA 5904441 AXIOM Artis BA 5904656 AXIOM Artis TA 7007755 AXIOM Artis FC: 10050; 10052; 10055; 10064; 10072; 10086; 10094; 10124; 10148; 10151; 10153; 10176; 10177; 10182; 10198; 10217; 10228; 10237; 10240; 10243; 10249; 10251; 10253; 10266; 10284; 10298; 10307; 10326; 10335; 10338; 10348; 10364; 10365; 10367; 10369 AXIOM Artis BC: 14007 AXIOM Artis MP: 20022; 20024; 20032; 20036; 20045; 20048; 20070; 20078; 20082; 20090; 20094; 20107; 20110; 20111; 20155; 20169; 20177; 20190; 20199; 20203; 20205

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)