RAYSEARCH LABORATORIES AB: Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6

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: 0 Lot/code info: Lot Code: UDI: 00735000201001320161214 GTIN: 07350002010013 Serial Numbers: 6.0.0.24 Software Revisions: RayStation 6 Expiration Date: 2021-12-22

UPC codes

07350002010013

Source

Official record: FDA (Device enforcement) ↗

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