The Recall Desk
HighFDA (Devices)·Z-0866-2020·Announced 2020-02-05

RayStation Treatment Planning Software Recalled for Dose Calculation Errors

RaySearch Laboratories is recalling RayStation software due to defects that may cause incorrect dose calculations during treatment planning.

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 where software defects could lead to incorrect dose calculations, but the source explicitly states that no patient mistreatment or other incidents have been reported.

Plain-English summary

RaySearch Laboratories AB is recalling the RayStation stand-alone software treatment planning system, including models 4.0 through 9.0. The recall involves 3,114 devices and licenses distributed nationwide in the United States.

The recall is due to three software issues: the Map ROI options may generate unintended geometries, there is an interoperability issue with Elekta guard leaf behavior, and the SSD parameter may incorrectly calculate source-to-skin distance instead of source-to-surface distance. These defects may result in incorrect dose calculations during treatment planning.

To the best of the manufacturer's knowledge, these issues have not caused any patient mistreatment or other incidents. Users must be aware of these issues to avoid incorrect dose calculations.

The recalled product

Product
RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
3,114

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 Versions Numbers: 4.0.0.14
  • 4.0.1.4
  • 4.0.2.9
  • 4.0.3.4
  • 4.3.0.14
  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

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