FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

Products

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
Brand
Siemens Medical Solutions USA, Inc
UPC
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.

Units Affected

182 active devices