Company:RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 4/1/2015
Class lI:

PRODUCT

RayStation Radiation Therapy Treatment Planning System; — RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Recall Number Z-1310-2015

REASON
RaySearch Laboratories AB became aware of an issue found with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.

RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, SE on 3/4/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
Domestic: 245 units

DISTRIBUTION
Nationwide.

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