The Recall Desk
HighFDA (Devices)·Z-1192-2025·Announced 2025-02-26

RayStation radiation therapy planning software density uncertainty computational defect

RayStation treatment planning software versions 4.5 through 2024B may incorrectly handle density uncertainty in radiation dose calculations for proton and light ion therapy. An inconsistency in three key functions could affect 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 recall affecting radiation therapy dose calculations. Although no injuries or illnesses are reported, this is a risk-of-harm product where computational errors in density uncertainty handling could affect dose accuracy in cancer treatment.

Plain-English summary

RayStation is a radiation therapy treatment planning system used to calculate doses for patients receiving proton or light ion therapy. The software versions 4.5 through 2024B, including certain service packs, are affected. The recall addresses an inconsistency in how the software handles density uncertainty when using HU-to-mass density CT calibration curves, specifically affecting three functions: Robust optimization, Robust evaluation, and Compute perturbed dose.

When density uncertainty is handled inconsistently in these functions, the calculated radiation dose may not accurately reflect the intended treatment plan. This could result in patients receiving incorrect dose distributions during radiation therapy.

RayStation is distributed worldwide. The affected software versions and specific identifiers are detailed in the FDA recall notice.

The recalled product

Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
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 (5)

  • Lot Code: UDI: 0735000201008220170529
  • 0735000201007520170630 and 0735000201024220190923 GTIN: 07350002010082
  • 07350002010075 and 07350002010242 Serial Numbers: 6.1.1.2
  • 6.2.0.7 and 6.3.0.6 Software Revisions: RayStation 6 Service Pack 1
  • 2 and 3 Expiration Date: 2024-10-18

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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