The Recall Desk
HighFDA (Devices)·Z-0736-2020·Announced 2020-01-01

RayStation Radiation Therapy Software Recalled for Beam Editing Bug

RaySearch Laboratories is recalling RayStation software versions 4.0 through 9.0 because a bug may reset beam settings, requiring dose recalculation.

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 involves a high-risk medical device (radiation therapy planning software) where a defect could lead to incorrect treatment parameters. The source text does not report any injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

RaySearch Laboratories AB is recalling RayStation stand-alone software treatment planning systems, including model numbers 4.0 through 9.0. The recall affects 956 devices and licenses distributed nationwide in the United States.

The recall is due to a software defect where editing a static arc beam may unexpectedly set the monitor unit (MU) of the beam to its initial default value of 200 MU. If this bug is triggered, the dose is invalidated and must be recalculated before the treatment plan can be approved or exported.

Clinically qualified radiation therapy staff using the system should check their software version against the list of affected versions. Users should ensure that any plans involving static arc beams are reviewed and recalculated if necessary to prevent the use of invalid dose parameters.

The recalled product

Product
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
956

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 (20)

  • Software Version Numbers: 4.0.0.14
  • 4.0.1.4
  • 4.0.2.9
  • 4.0.3.4
  • 4.5.0.19
  • 4.5.1.14
  • 4.5.2.7
  • 4.7.0.15
  • 4.7.1.10
  • 4.7.2.5
  • 4.7.3.13
  • 4.7.4.4
  • 4.7.5.4
  • 4.9.0.42
  • 5.0.0.37
  • 5.0.1.11 5.0.2.35
  • 6.0.0.24
  • 6.1.0.26
  • 6.1.1.2
  • 6.2.0.7

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

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