RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.

RaySearch Laboratories sent an Urgent Field Safety Notice, Medical Device Correction letter dated January 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to educate their planning staff and all users about the recommended workarounds contained in the letter. Customers were also asked to inspect their product and identify all installed units that were infected and then complete the attached Reply Form and e-mail or scan a copy of the completed form to the firm. Customers were instructed to pass along this information to all those who need to be aware of this Medical Device Correction Customers with questions were instructed to contact the RaySearch support email at support@raysearchlabs. For questions regarding this recall call +46 8 545 06130.