The Recall Desk
HighFDA (Devices)·Z-2290-2018·Announced 2018-07-04

RayStation Radiation Therapy Software Recalled for Dose Calculation Accuracy Issues

RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software versions 6.0 through 7.0 because dose calculation accuracy may be less than expected in some situations.

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 medical device used for radiation therapy where incorrect dose calculations could lead to harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

RaySearch Laboratories AB is recalling the RayStation Radiation Therapy Treatment Planning System software, specifically versions 6.0, 6.1, 6.2, and 7.0. The recall involves 728 units distributed nationwide in the United States, including states such as Alabama, Arizona, California, Florida, New York, and Texas. The affected software versions include build numbers 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, and 7.0.0.19.

The recall was initiated because the dose calculation accuracy of the software may be less than expected in some situations. RayStation is a software system designed for treatment planning and analysis of radiation therapy, providing treatment unit set-up parameters and estimates of dose distributions. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Clinically qualified radiation therapy staff who use this system should be aware of the potential for incorrect dose calculations during treatment planning. Users must verify their specific software version against the listed build numbers and consult with their vendor or the FDA for instructions on how to proceed to ensure patient safety and accurate treatment planning.

The recalled product

Product
RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of d
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
728

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 (4)

  • 6.0.0.24
  • 6.1.0.26
  • 6.1.1.2
  • 6.2.0.7 and 7.0.0.19

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

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