RAYSEARCH LABORATORIES AB recalls RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy T…

Recall date

July 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2206-2016

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

California, Connecticut, Delaware, Florida, Hawaii, Maine, Missouri, New York, Ohio, Texas and Washington

Why it was recalled

An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.