Company RAYSEARCH LABORATORIES AB.
Date of Enforcement Report:4/9/2014
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software.Recall Number Z-1308-2014
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
RAYSEARCH LABORATORIES AB, Stockholm, Sweden on.2/6/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
19 units (16 units domestically & 3 units internationally)
Nationwide and Internationally