Z-1299-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2022
- Initiation Date
- June 10, 2022
- Termination Date
- June 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
Product Description
RayStation 11B
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 Pattern
US Nationwide distribution in the states of NJ and TX.
Code Information
UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68