Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1110-2026 — Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

U.S. FDA — Device Enforcement · Sweden · 2025-11-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1110-2026
Date of alert
2025-11-28
Country / jurisdiction
Sweden
Risk level
Class II
Risk type
recall
Brand
RAYSEARCH LABORATORIES AB
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07350002010822
Reported risk: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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