Company RAYSEARCH LABORATORIES AB.
Date of Enforcement Report:4/9/2014
Class lI:
PRODUCT
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Recall Number Z-1307-2014
REASON
Potential for dose errors due to software program errors..
RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, Sweden on.2/6/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
151 units Total (88 units domestically & 63 units internationally)
DISTRIBUTION
Nationwide and Internationally
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