medical Class II Updated 2025-02-26

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

Recalled Product

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B


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: 0735000201054920220616, 0735000201067920221007, 0735000201073020230913 and 0735000201055620230630 GTIN: 07350002010549, 07350002010679, 07350002010730 and 07350002010556 Serial Numbers: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Revisions: RayStation 12A, 12A Service Pack 1 and 2 and 2023B Expiration Date: 2028-07-07
View official government recall

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