RAYSEARCH LABORATORIES AB: Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 1 Lot/code info: Lot Code: UDI: 0735000201008220170529, 0735000201007520170630 and 0735000201024220190923 GTIN: 07350002010082, 07350002010075 and 07350002010242 Serial Numbers: 6.1.1.2, 6.2.0.7 and 6.3.0.6 Software Revisions: RayStation 6 Service Pack 1, 2 and 3 Expiration Date: 2024-10-18

UPC codes

07350002010082, 07350002010075, 07350002010242

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.