Z-1092-2012

ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Manufactured by...

Name: Z-1092-2012 ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Manufactured by...
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-01-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-01-22 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Manufactured by Siemens AG, Kemnath, Germany. The indication is to... on 2012-01-22. The reason FDA records is "Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1092-2012
Status: Terminated
Initiated: 2012-01-22
Posted: 2012-02-23
Terminated: 2012-11-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Manufactured by Siemens AG, Kemnath, Germany. The indication is to deliver X-ray, photon and electron radiation for the therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment.
Root cause tag: software
FDA root cause: Software design
Action: Siemens customers with active devices will receive the software update through the distribution of the "Update Instructions" with a release date of January 22, 2012. The software update will be delivered and installed by a qualified Field Service Engineer utilizing a SW kit and instruction distributed by the Update instruction. Consignee notification of the Update Instructions will be delivered by Customer Service or by certified mail.
Quantity in commerce: 182 active devices
Distribution: Worldwide Distribution - USA, including the states of WI, UT, PA, TN, OH, LA, DE, MI, NJ, FL, NE, WV, MO and the countries of Germany, Spain, Poland, Australia, Malaysia, New Zealand, India, Republic of Korea, Canada, Italy, Egypt, Philippines, France, Belgium, Saudi Arabia, South Africa, Norway, Turkey , Hungary, Russian Federation, P.R. China, Lebanon, Iran, and the United Kingdom.
Product codes and lots: Syngo RT Therapist v4.1, part number 8162815; Syngo RT Therapist Assist (off line system), part number 8162807; Syngo RT Express Basic (stand alone system), part number 8151289; and Syngo RT Express Assist (offline system), part number 8151297.

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)