Company:RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 9/9/2015
Class lI:
PRODUCT
Radiation Therapy Treatment Planning System software 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-2785-2015
REASON
An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, SE on 5/29/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
20
DISTRIBUTION
State of WA and intenationally
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