Company:RAYSEARCH LABORATORIES AB.
Date of Enforcement Report 1/24/2018
Class lI:
PRODUCT
RayStation Product Usage: 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-0380-2018
REASON
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, Sweden. on 7/17/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
117 units
DISTRIBUTION
Nationwide
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