Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1

Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

Code information: Lot Code: UDI: 0735000201006820171130, 0735000201011220180608 and 0735000201013620180928 GTIN: 07350002010068, 07350002010112 and 07350002010136 Serial Numbers: 7.0.0.19, 8.0.0.61 and 8.0.1.10 Software Revision: RayStation 7, 8A and 8A Service Pack 1 Expiration Date: 2023-10-04

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, SwitzerlandENG, Taiwan, Thailand, UK.