The Recall Desk
HighFDA (Devices)·Z-0478-2021·Announced 2020-12-02

RayStation software recall for potential incorrect treatment plan references

RaySearch Laboratories is recalling RayStation software because missing data may cause treatment plans to reference incorrect regions or points of interest.

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 medical device software defect that could lead to incorrect treatment planning, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

RaySearch Laboratories AB is recalling RayStation standalone software treatment planning systems, including models 4.0 through 10.0. The recall involves 2,768 units distributed nationwide in the United States.

The recall is due to a software defect where a region of interest (ROI) or point of interest (POI) referenced from an imported plan may become linked to the wrong ROI or POI if that specific data is missing in the imported RT Structure Set. This could result in incorrect treatment plan references.

Authorized intended users should contact RaySearch Laboratories for instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
RayStation standalone software treatment planning system, Model No. 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, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation propose
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
2,768

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
  • 4.0.3.4
  • 4.5.1.14
  • 4.7.2.5
  • 4.7.3.13
  • 4.7.4.4
  • 4.7.5.4
  • 4.7.6.7
  • 4.9.0.42
  • 5.0.1.11
  • 5.0.2.35
  • 5.0.3.17
  • 6.0.0.24
  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · RAYSEARCH LABORATORIES AB

See all →

Same hazard · software defect

See all →