The Recall Desk
HighFDA (Devices)·Z-1188-2025·Announced 2025-02-26

Medical Device RayStation Dosage Calculation Inconsistency in Radiation Therapy Planning

RayStation radiation therapy treatment planning software contains an inconsistency in how it handles density uncertainty during dose calculations for proton and light ion treatments, potentially affecting treatment planning accuracy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall without reported injuries or hospitalizations. The inconsistency in dose calculation poses a potential risk of harm to treatment planning accuracy, but no patient injury has been reported in the source. This meets the High severity criterion for risk-of-harm medical devices without reported injury.

Plain-English summary

RayStation is a radiation therapy treatment planning system manufactured by RaySearch Laboratories. Versions 10.1.0.613 (RayStation 10B) and 10.1.1.54 (10B Service Pack 1) contain an inconsistency in how the software handles density uncertainty when calculating treatment doses for proton and light ion therapies.

The problem affects three software functions: Robust optimization, Robust evaluation, and Compute perturbed dose. When using a HU-to-mass density CT (Hounsfield Unit) calibration curve, the software does not consistently account for density uncertainty, which could lead to incorrect dose calculations during treatment planning.

This recall affects radiation therapy treatment planning facilities worldwide, including locations in the United States, Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, Switzerland, Taiwan, Thailand, and the United Kingdom.

Healthcare facilities using affected versions of RayStation should contact RaySearch Laboratories for software updates and verification procedures for treatment plans created with the affected software.

The recalled product

Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning
Hazard

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by RAYSEARCH LABORATORIES AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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