Recall Z-0459-2012 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer.
| Date | Jan 11, 2012 (initiated Nov 9, 2011) |
| Status | Terminated |
| Reason | Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line. |
| Root cause | Component design/selection |
| Action | Siemens Medical Solutions USA, Inc. sent a Customer Information letter dated November 9, 2011, by federal express. The letter identified the product the problem and the action needed to be taken by the customer. The HW Update included information regarding the potential problem and provide instructions in the Safety update. Further questions call (925) 602-8157. |
| Quantity | 13 active devices |
| Distribution | Worldwide Distribution-- USA ( nationwide ) including the states of : MO, NC, OH, and OK and the countries of Turkey, Japan, Germany and Portugal |
| FDA record | Open on fda.gov |