The Recall Desk
HighFDA (Devices)·Z-0849-2022·Announced 2022-04-06

Radiation therapy planning software: incorrect dose density calculation

RayStation/RayPlan radiation therapy software (versions 4–11A) may incorrectly calculate radiation dose density in treatment planning. The error affects dose calculations in regions partially covered by certain structures.

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: The calculation error affects critical dose determinations in radiation therapy planning, but the source text reports no actual injuries, hospitalizations, or adverse events. Per the FDA severity rubric, a risk-of-harm product without reported injury qualifies as High. Class II classification applies.

Plain-English summary

The FDA has recalled RayStation/RayPlan versions 4 through 11A, software used in healthcare facilities to calculate and plan radiation therapy treatments. The recall affects 478 licensed copies distributed nationwide in the United States.

The software contains an error in dose grid voxel density calculations. When voxels are partially covered by certain regions of interest (ROIs)—specifically Bolus, Support, or Fixation regions—the density values may be incorrectly estimated. Affected voxels can show either underestimated or overestimated density, potentially leading to inaccurate radiation dose calculations in treatment plans.

Healthcare facilities using RayStation/RayPlan versions listed in the recall should contact RaySearch Laboratories AB for corrected software versions. Treatment plans created with affected software should be reviewed to verify dose calculation accuracy. Consult the FDA recall notice for specific build version numbers and UDI codes for each affected product version.

The recalled product

Product
RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47,
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning Software
Hazard
  • dose-calculation-error
  • software-defect

Distribution

Distributed nationwide across the United States.

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