Company: RAYSEARCH LABORATORIES AB.
Date of Enforcement Report: 7/4/2018
Class II:
PRODUCT
RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user Recall Number: Z-2290-2018
REASON
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
RECALLING FIRM/MANUFACTURER
IRAYSEARCH LABORATORIES AB, Stockholm, Sweden on 3/22/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
728
DISTRIBUTION
Nationwide.