Recall Z-1092-2012 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
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.
| Date | Feb 23, 2012 (initiated Jan 22, 2012) |
| Status | Terminated |
| Reason | 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 | 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 | 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, Tu |
| FDA record | Open on fda.gov |