Z-1732-2010

Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355...

Name: Z-1732-2010 Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355...
Creator: Siemens Medical Solutions USA, Inc
Published: 2010-04-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-04-12 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use on 2010-04-12. The reason FDA records is "sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1732-2010
Status: Terminated
Initiated: 2010-04-12
Posted: 2010-05-28
Terminated: 2013-04-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens issued an "Urgent Field Safety Notice" to consignees describing the affected device instructing users to contact the recalling firm's service organization to schedule maintenance. For further information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-3237.
Quantity in commerce: 83 units
Distribution: Nationwide Distribution
Product codes and lots: Model Numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717 and 7728392.

Product code MQB

K021021Class IIModular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. / cleared 2002-06-06

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)