medical Class II Updated 2021-08-04

RAYSEARCH LABORATORIES AB recalls RayStation (Radiation Treatment Planning System) : RayStati

Recalled Product

RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; RayStation 10.0 (10.0.0.1154) 07350002010303; RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365; RayStation 10.1 (10.1.0.613) 07350002010310; RayStation 11.0 (11.0.0.951) 07350002010389;

Hazard / Issue

Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

Issued by

FDA

Affected States: TN

Lot/Code Info: Product name (build number) UDI-DI RayStation 9.0 (9.0.0.113) 07350002010174 RayStation 9.1 (9.1.0.933) 07350002010266 RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297 RayStation 10.0 (10.0.0.1154) 07350002010303 RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365 RayStation 10.1 (10.1.0.613) 07350002010310 RayStation 11.0 (11.0.0.951) 07350002010389

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