Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 6/5/2013
Class ll:
PRODUCT
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number Z-1419-2013
REASON
Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, Sweden on 2/15/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Domestic: 70 units; Foreign: 27 units
DISTRIBUTION
Nationwide and Internationally
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