Recall Z-1299-2022 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation 11B
| Date | Jun 10, 2022 |
| Status | Terminated |
| Reason | This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam. |
| Root cause | Under Investigation by firm |
| Action | The firm notified customers of the recall via email on June 10, 2022. The notice was titled "Field Safety Notice, Medical Device Correction #99834." Customers were given precautions and instructed on a workaround. The issue will be resolved in the next version of RayStation, scheduled for market release in June 2022, though this may be subject to market clearance. |
| Quantity | 26 |
| Distribution | US Nationwide distribution in the states of NJ and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220141 | RayStation 11B RaySearch Laboratories AB (PUBL), Apr 15, 2022 |