RayStation 11B
- Recall Initiated
- June 10, 2022
- Terminated
- June 11, 2024
- Recall Number
- Z-1299-2022
- Quantity
- 26
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of NJ and TX.
Lot / Code Info
UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68
Root Cause
Under Investigation by firm
Action Taken
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.