Recall Z-1645-2014 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.
| Date | May 21, 2014 (initiated Apr 1, 2014) |
| Status | Terminated |
| Reason | Table may lose calibration during patient treatment, which may cause the possibility of mistreatment. |
| Root cause | Software design |
| Action | Siemens sent an Medical Device Correction, Field Safety Notice of Improvement to End users in March 2014, informing them that a Siemens representative would install a software update. By installation of this software update the issues were solved by the following actions: 1. A plausibility check was introduced for comparing the two independent encoder systems of each table axis. 2. The time between two encoder comparisons was reduced to 50ms and an error code was introduced. Please include this Field Safety Notice in your Digital Linear Accelerator System Owner Manual chapter "Safety |
| Quantity | 120 |
| Distribution | USA ( nationwide) Distribution. |
| FDA record | Open on fda.gov |