Company:RaySearch Laboratories AB
Date of Enforcement Report 1/25/12
Class ll:
PRODUCT
RayStation Version 2.0.0.15 Consult instruction for use. 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. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system. Recall # Z-0359-2012
REASON
The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.
RECALLING FIRM/MANUFACTURER
RaySearch Laboratories AB, Stockholm, Sweden, by letter dated October 19, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
19 Units (14 units Nationwide; 5 units Internationally)
DISTRIBUTION
Nationwide and Netherlands
