The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0732-2022·Announced 2022-03-16

Radiation therapy planning software displays wrong images during animation playback

RayStation/RayPlan versions 6.0.0.24 through 9.2.0.483 incorrectly display selected images as both primary and secondary when animation playback is running, affecting treatment planning visualization.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device with a display defect affecting radiation therapy treatment planning visualization. No illnesses or injuries reported; this is a preventable risk-of-harm scenario addressed through software updates.

Plain-English summary

RayStation/RayPlan is FDA-cleared medical device software designed for radiation therapy treatment planning and analysis. Multiple software versions (6.0.0.24 through 9.2.0.483) contain a defect in the image display system.

When a user selects a new primary image set while the cine loop (animation playback) is running, the software incorrectly displays the selected image set as both the primary and secondary image in all side-by-side viewing modes. The same display error occurs when a new patient or case is opened while the cine loop is running.

The defect affects radiation therapy centers across the United States where 75 licenses of the software are deployed. Users should contact RaySearch Laboratories AB for available software updates and guidance to prevent treatment planning errors.

The recalled product

Product
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 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 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 .…
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning
Hazard
Affected units
75

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 (13)

  • Software: 6.0.0.24
  • 6.1.0.26
  • 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
  • 8.1.1.8
  • 8.1.2.5
  • 9.0.0.113
  • 9.1.0.933

Distribution

Distributed nationwide across the United States.

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