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.
Recall
- Recall Number
- Z-1092-2012
- Event Number
- 61121
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2937457
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- January 22, 2012
- Posted
- February 23, 2012
- Terminated
- November 7, 2012
- Address
- 4040 Nelson Ave, Concord, CA, 94520-1200
Description
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.
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.
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.
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.
182 active devices