FDAJanuary 16, 2025device

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

raysearch laboratories abraysearchraysearch laboratories

UPCs

07350002010389073500020104330735000201044007350002010631

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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