The Recall Desk
HighFDA (Devices)·Z-1195-2025·Announced 2025-02-26

RayStation Radiation Therapy Software Recalled for Dose Calculation Inconsistency

RayStation radiation therapy planning software is being recalled due to inconsistent handling of density uncertainty in dose calculations for proton and light ion treatment plans. The software defect may affect the accuracy of calculated radiation doses.

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: This is an FDA Class II recall involving a potential software defect in radiation therapy planning calculations with no reported deaths, hospitalizations, or confirmed patient injuries. Per the severity rubric, recalls involving risk-of-harm products where injury has not been reported are classified as High.

Plain-English summary

RayStation, a radiation therapy treatment planning system, is being recalled due to inconsistent handling of density uncertainty in version 4.5 through 2024B (versions 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5, and 4.7.6). The defect affects three specific software functions: Robust optimization, Robust evaluation, and Compute perturbed dose when planning proton and light ion therapy treatments.

The issue occurs when using the HU-to-mass density (Hounsfield Unit) CT calibration curve in the affected versions. The inconsistent application of density uncertainty could result in inaccurate dose calculations for radiation therapy treatment plans.

RayStation has been distributed worldwide to healthcare facilities in the United States and numerous other countries including Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, India, Italy, Japan, Korea, the Netherlands, Norway, Poland, Singapore, Spain, Switzerland, Taiwan, Thailand, and the United Kingdom.

The manufacturer, RaySearch Laboratories AB, has issued this Class II recall notice.

The recalled product

Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning
Hazard
  • dose-calculation-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Lot Code: Serial Numbers: 4.5.1.14
  • 4.7.2.5
  • 4.7.3.13
  • 4.7.4.4
  • 4.7.5.4 and 4.7.6.7 Software Revisions: RayStation 4.5.1
  • 4.7.2
  • 4.7.3
  • 4.7.4
  • 4.7.5 and 4.7.6 Expiration Date: 2025-03-17

Distribution

Distributed nationwide across the United States.

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