Recall Z-2789-2011 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS. The Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
| Date | Jul 11, 2011 (initiated May 25, 2011) |
| Status | Terminated |
| Reason | Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system |
| Root cause | Software design |
| Action | Siemens Customers Service group began providing Update Instructions and installing the software update on affected machines beginning May 25, 2011. A customer information letter was also provided. |
| Quantity | 45 customers with affected configuration in US, 37 customers ROW. |
| Distribution | Worldwide Distribution - USA including distribution to LA, CA, PA, MA, NE, NJ, DE, WI, NC, NY, WI, MD, FL, KY and to Poland, Netherlands, Ireland, G=Belgium, Germany, New Zealand, P.R. China, Saudi Arabia, Australia, Malaysia, Egypt, Canada, and Spain. |
| FDA record | Open on fda.gov |