Z-1299-2022 Class II Terminated
FDA device recall Z-1299-2022 was initiated by RAYSEARCH LABORATORIES AB on Jun 10, 2022 and is designated Class II. 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… The recall status is terminated (terminated Jun 11, 2024). Affected quantity: 26.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 6, 2022
- Initiation Date
- Jun 10, 2022
- Termination Date
- Jun 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1299-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026