The Recall Desk
HighFDA (Devices)·Z-1186-2025·Announced 2025-02-26

RayStation radiation therapy planning software density uncertainty calculation inconsistency

RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in density uncertainty handling when HU-to-mass density CT calibration curves are used. No illnesses or injuries have been reported.

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 medical device recall involving a potential inconsistency in radiation therapy planning software with no reported injuries or illnesses, making it a risk-of-harm scenario without documented adverse events.

Plain-English summary

RayStation is a radiation therapy treatment planning system distributed worldwide, including throughout the United States. The FDA has identified an inconsistency in how versions 4.5 through 2024B of the software (including some service packs) handle density uncertainty in three specific functions: Robust optimization, Robust evaluation, and Compute perturbed dose. This inconsistency occurs when HU-to-mass density CT calibration curves are used in proton and light ion treatment planning.

Healthcare facilities using RayStation should contact RAYSEARCH LABORATORIES AB to determine if their software version is affected and to obtain updates or corrective measures. No illnesses or injuries have been reported in connection with this issue.

The recalled product

Product
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning
Hazard
Affected units
1

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: UDI: 0735000201011220180608
  • 0735000201013620180928
  • 0735000201017420190612 and 0735000201048820220420 GTIN: 07350002010112
  • 07350002010136
  • 07350002010174 and 07350002010488 Serial Numbers: 8.0.0.61
  • 8.0.1.10
  • 9.0.0.113 and 9.0.1.142 Software Revisions: RayStation 8B
  • 8B Service Pack 1 and 2
  • 9A and 9A Service Pack 1 Expiration Date: 2027-12-15

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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