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: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2


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: 0735000201026620191220, 0735000201029720200310, 0735000201030320200526, 0735000201036520200526 and 0735000201065520220608 GTIN: 07350002010266 and 07350002010297, 07350002010303, 07350002010365 and 07350002010655 Serial Numbers: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Revisions: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2 Expiration Date: 2025-06-16
View official government recall

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