FDA-Device2022-07-27Class II

RayStation 9B SP1. For radiation treatment planning.

RAYSEARCH LABORATORIES AB
Hazard

An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

Sold states
Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.
Affected count
1
Manufactured in
Sveavagen 9, N/A, Stockholm, N/A, Sweden
Products
RayStation 9B SP1. For radiation treatment planning.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1403-2022

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