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.
This recall has been terminated (originally issued February 23, 2012).
- Recall Initiated
- January 22, 2012
- Posted
- February 23, 2012
- Terminated
- November 7, 2012
- Recall Number
- Z-1092-2012
- Quantity
- 182 active devices
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Software design
Action Taken
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.