medical Class II Updated 2025-02-26

RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Intended as a Radiation Therapy Treat

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →