The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0038-2017·Announced 2016-10-12

RayStation Radiation Therapy Planning Software Recalled for Dose Calculation Errors

RaySearch is recalling RayStation software versions 2.5 through 5.0 due to dose calculation errors when using specific region of interest settings.

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 3/5 (High).

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 used for radiation therapy planning where dose calculation errors could lead to incorrect treatment, representing a risk of harm where injury has not yet been reported.

Plain-English summary

RaySearch Laboratories AB is recalling RayStation Radiation Therapy Treatment Planning System software versions 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0, and 4.3 (InverseArc 1.0). The recall involves 522 units in the United States and 846 units outside the United States. The software is used to plan and analyze radiation therapy treatments.

The recall was initiated after RaySearch discovered issues with dose calculations when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline. The problem was identified during cooperation with a customer experimenting with dose calculation on a phantom. The affected build numbers include 2.5.0.144, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 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, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, and 5.0.2.35.

Healthcare providers and users of the affected software should contact RaySearch Laboratories AB for information on the correction. The source text does not specify a specific action for consumers, as the product is a professional medical device.

The recalled product

Product
RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters…
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning Software
Hazard

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 Numbers: 2.5.0.144
  • 2.5.1.89
  • 3.0.0.251
  • 3.5.0.16
  • 3.5.1.6
  • 4.0.0.14
  • 4.0.1.4
  • 4.0.2.9
  • 4.0.3.42
  • 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
  • 4.7.4.4
  • 4.7.5.4
  • 5.0.0.37
  • 5.0.1.11 or 5.0.2.35.

Distribution

Distributed nationwide across the United States.

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