The Recall Desk
HighFDA (Devices)·Z-1806-2014·Announced 2014-06-25

RayStation Software Recall for Radiation Therapy Dose Calculation Errors

RaySearch Laboratories is recalling RayStation software version 4.0.3.4 due to a bug that causes incorrect dose calculations for radiation therapy plans with variable CT slice spacing.

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 recall is classified as FDA Class II and involves a risk-of-harm product (radiation therapy planning software) where the defect can lead to incorrect dose calculations, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

RaySearch Laboratories AB is recalling RayStation software version 4.0.3.4, a system used for treatment planning and analysis of radiation therapy. The recall involves 25 sites and 245 units in the United States, as well as 25 sites and 124 units in foreign countries. The software was distributed nationwide in the US and in several international locations including Australia, Belgium, Germany, France, Italy, New Zealand, the Republic of Korea, Switzerland, Spain, and the United Kingdom.

The recall is due to a software defect affecting the computation of region of interest (ROI) voxel volumes when computed tomography (CT) images have variable slice spacing. This error can result in an incorrect volumetric representation of the ROI, which affects dose-volume properties such as dose-volume histograms (DVH), dose statistics, and clinical goals. Additionally, the bug can trigger errors in the 3D dose distribution if material override ROIs are used or if the external body is not represented by contours.

Healthcare facilities using this specific version of the software should contact RaySearch Laboratories for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard

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 (1)

  • Software version 4.0.3.4

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

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