medical Class II Updated 2018-11-07

RAYSEARCH LABORATORIES AB recalls RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 a

Recalled Product

RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.


Hazard / Issue

Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software, include version number: 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10, 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 5.0.0.37 , 5.0.1.11 , 5.0.2.3 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19
View official government recall

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