Official recall record
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
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-01-16
- Country of alert
- Sweden
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 07350002010266
- Brand on record
- RAYSEARCH LABORATORIES AB
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2020-02-20 · US FDA — Medical Devices
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Other recalls from this brand
- 2025-11-28 · US FDA — Medical Devices
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStat - 2025-11-28 · US FDA — Medical Devices
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1. - 2025-11-28 · US FDA — Medical Devices
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Softwa
All 15 official recall notices naming RAYSEARCH LABORATORIES AB on this site →