The Recall Desk
HighFDA (Devices)·Z-2554-2018·Announced 2018-08-01

RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

RaySearch Laboratories is recalling RayStation software due to erroneous beam profile parameters that may cause incorrect dose calculations in large or off-axis fields.

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 with a defect that could lead to incorrect dose calculations in radiation therapy. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

RaySearch Laboratories AB is recalling 718 units of the RayStation Radiation Therapy Treatment Planning System, including models 2.5 through 7.0. The recall affects software versions distributed nationwide in the United States.

The recall was initiated because some users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in the corners of large or off-axis fields. The issue is not visible in the Beam Commissioning module, meaning users must validate dose in large or off-axis fields using the Beam 3D Modeling module in RayPhysics/RayPlan Physics to avoid incorrect dose calculations during treatment planning.

Intended users, who are clinically qualified radiation therapy staff, should be aware of this potential for incorrect dose calculations. The source text does not specify specific corrective actions or contact information for users.

The recalled product

Product
RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
718

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)

  • 2.5.1.89
  • 3.5.0.16
  • 3.5.1.6
  • 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

Distribution

Distributed nationwide across the United States.

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Same hazard · incorrect dose calculation

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