Cl II RayStation treatment planning systems

Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report 7/27/2016
Class lI:

PRODUCT

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.
Recall Number Z-2206-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, Sweden on 7/1/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
170 units

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

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.