The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0294-2019·Announced 2018-11-07

RayStation Software Recalled for Unsupported Robust Optimization Feature

RaySearch Laboratories AB is recalling RayStation software versions 4.5 through 7 because robust optimization for specific plans is not supported.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a software functionality limitation rather than a direct physical injury risk, fitting the criteria for a moderate severity score.

Plain-English summary

RaySearch Laboratories AB is recalling RayStation 4.5, 4.7, 5, 6, and 7, a stand-alone software treatment planning system. The recall involves 110 units distributed nationwide.

The recall is issued because robust optimization for plans using beam set + background dose is not supported in these software versions. This limitation affects the functionality of the treatment planning system.

No specific instructions for consumers are provided in the source text, but the recall is limited to the specified software versions and units.

The recalled product

Product
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Software
Hazard
Affected units
110

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 (18)

  • Software
  • include version number: 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
  • 5.0.0.37
  • 5.0.1.11
  • 5.0.2.3
  • 6.0.0.24
  • 6.1.0.26
  • 6.1.1.2
  • 6.2.0.7
  • 7.0.0.19

Distribution

Distributed nationwide across the United States.

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