Company: RAYSEARCH LABORATORIES AB.
Date of Enforcement Report 4/30/2014
Class lI:
PRODUCT
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Recall Number Z-1481-2014
REASON
RaySearch Laboratories has recalled “RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0” software due to dose miscalculations for bolus/external/fixation support structures on CT-image..
RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, Sweden on 2/14/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
251 units
DISTRIBUTION
Nationwide and Internationally
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