FDA Device recall Z-1194-2025

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Vers…

• FDA Device
• Class II
• ongoing
• Published 2025-02-26

On 2025-02-26 the FDA classified a Class II recall of Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Vers… by Raysearch Laboratories Ab, citing 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 pl….

Read the official FDA Device notice

Product

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1194-2025%22

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