The Recall Desk
HighFDA (Devices)·Z-1597-2021·Announced 2021-05-26

RayStation Software Recall Due to Dose Labeling Error in Merged Beams

RaySearch Laboratories is recalling RayStation and RayPlan software versions due to a defect that may mislabel approximate radiation doses as clinical doses.

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 significant dosing errors in radiation therapy, particularly for sensitive areas like the lung, which fits the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

RaySearch Laboratories AB is recalling specific versions of its RayStation and RayPlan standalone software treatment planning systems. The affected units include RayStation versions 4.5 through 10B and RayPlan versions 1, 2, 7, 8A, 8B, 9A, 10A, and 10B, along with certain service packs. A total of 116 units were distributed nationwide in the United States.

The recall is issued because, for certain Linear Accelerator (LINAC) types, merging clinical beams with beams of approximate dose may result in the approximate dose being erroneously labeled as clinical dose. This error can occur when using manual merging, scripting, or the Automated breast planning feature. In these cases, the resulting beam is labeled as "Clinical" even though some segments are calculated with the SVD dose engine and should be labeled "Approximate: Mixed dose." While the difference between approximate and final clinical dose is often small, it can be significant for body sites such as the lung.

Healthcare providers using these software versions should contact RaySearch Laboratories for instructions on how to address the issue. Users should verify their software build numbers against the list provided in the official recall notice to determine if their system is affected.

The recalled product

Product
RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
116

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)

  • Build number: 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
  • 8.1.1.8
  • 8.1.2.5

Distribution

Distributed nationwide across the United States.

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