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; Ray
Check against the official notice below — it lists the full affected range.
RaySearch Laboratories AB is recalling RayStation radiation treatment planning system software, specifically versions 9A, 9B, 9B SP1, 10A, 10A SP1, 10B, and 11A when used in combination with RayCare. The problem is that initial delivery positions will be set incorrectly when setup beams are present at the localization point. Five units were distributed in the United States (Tennessee) and Belgium.
The recall notice does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
Reason for recall: Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point. Distribution: US distribution to TN; and Belgium Quantity: 5 units 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.