RAYSEARCH LABORATORIES AB: Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Ser

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: 0735000201031020201216 and 0735000201047120220128 GTIN: 07350002010310 and 07350002010471 Serial Numbers: 10.1.0.613 and 10.1.1.54 Software Revisions: RayStation 10B and 10B Service Pack 1 Expiration Date: 2027-02-01

UPC codes

07350002010310, 07350002010471

Source

Official record: FDA (Device enforcement) ↗

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