medical Class II Updated 2022-07-06

RAYSEARCH LABORATORIES AB recalls RayStation 11B

Recalled Product

RayStation 11B


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68
View official government recall

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