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: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A 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: 0735000201011220180608, 0735000201013620180928, 0735000201017420190612 and 0735000201048820220420 GTIN: 07350002010112, 07350002010136, 07350002010174 and 07350002010488 Serial Numbers: 8.0.0.61, 8.0.1.10, 9.0.0.113 and 9.0.1.142 Software Revisions: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1 Expiration Date: 2027-12-15
View official government recall

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