Recall Z-0441-2022 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
| Date | Dec 9, 2021 |
| Status | Terminated |
| Reason | Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury |
| Root cause | Other |
| Action | Siemens issued Urgent Medical Device Corrction Letter CSAN TH001/21/S on 12/09/2021 to inform them of the potential issue and associated risk. Acton to take: 1. Carefully verify all planned treatment parameters against those actually set during patient setup before treating a patient. 2. Choose one of the following workflow options: - Use absolute table positions. In this case, positioning on a different isocenter would not match the planned table values and the system would prompt an override request. This minimizes the risk of selecting a wrong site fraction group. Or - In the case of mulit |
| Quantity | 13 units |
| Distribution | US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142434 | ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 Siemens Medical Solutions USA, Inc., Nov 21, 2014 |