The Recall Desk
HighFDA (Devices)·Z-0721-2017·Announced 2016-12-14

RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

RaySearch Laboratories is recalling RayStation software versions 4.0, 4.5, 4.7, and 5.0 due to potential inaccuracies in proton dose calculations for specific treatment plans.

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 inaccurate radiation dose calculations, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

RaySearch Laboratories AB is recalling RayStation 4.0, 4.5, 4.7, and 5.0 Radiation Therapy Treatment Planning Systems. The recall involves 66 units distributed nationwide in the United States, specifically in California, Florida, Illinois, Louisiana, Michigan, New Jersey, Tennessee, Texas, and Washington.

The recall is due to a software anomaly affecting the proton Pencil Beam Scanning (PBS) dose calculation. For treatment plans that include a combination of a range shifter, a large air gap, and beams entering the patient surface at an oblique angle, the dose calculation accuracy may be less than expected. This could result in treatment plans providing inaccurate dose distribution estimates.

The affected software builds include specific versions ranging from 4.0.2.9 to 5.0.2.35. Intended users are clinically qualified radiation therapy staff. No specific instructions for consumers are provided in the source text, as the product is used by medical professionals.

The recalled product

Product
RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose d
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
66

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 (13)

  • Build numbers: 4.0.2.9
  • 4.0.3.4
  • 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 or 5.0.2.35

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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