Recall Z-0472-2023 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
| Date | Dec 9, 2022 (initiated Nov 9, 2022) |
| Status | Open, Classified |
| Reason | When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter |
| Root cause | Software design |
| Action | Siemens issued Urgent Medical Device Correction Letter CSAN TH001/22/S to all affected customers on 11/09/2022. Letter states reason for recall, health risk and action to take: Siemens is developing the new syngo RT Therapist (RTT) software version RTT 4.3.1 MR4. With the new software version, the User will be able to load only one site at a time and avoid confusion of multiple displayed sites. If the User tries to download multiple sites from ARIA to syngo RT Therapist (RTT), the RTT will reject the complete patient load. If this occurs, User should immediately change their workflow by prepar |
| Quantity | 8 units US |
| Distribution | US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC. |
| 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 |