Z-0459-2012

ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens...

Name: Z-0459-2012 ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens...
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-11-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-11-09 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath... on 2011-11-09. The reason FDA records is "Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line". 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-0459-2012
Status: Terminated
Initiated: 2011-11-09
Posted: 2012-01-11
Terminated: 2013-04-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens Medical Solutions USA, Inc. sent a Customer Information letter dated November 9, 2011, by federal express. The letter identified the product the problem and the action needed to be taken by the customer. The HW Update included information regarding the potential problem and provide instructions in the Safety update. Further questions call (925) 602-8157.
Quantity in commerce: 13 active devices
Distribution: Worldwide Distribution-- USA ( nationwide ) including the states of : MO, NC, OH, and OK and the countries of Turkey, Japan, Germany and Portugal
Product codes and lots: Artiste MV system, part number 8139789 ONCOR Impression PLUS, part number 5857912

Product code IYE

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)