RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden RayStation 11B Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RayStation 11B
Brand
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
Lot Codes / Batch Numbers
UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68
Products Sold
UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68
RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden is recalling RayStation 11B due to This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, w. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026