The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1815-2017·Announced 2017-04-19

RayStation Radiation Therapy Software Recalled for GPU Driver Error

RaySearch Laboratories is recalling RayStation software due to a potential calculation error in non-standard Citrix environments.

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 software error that could lead to erroneous treatment calculations, representing a risk of harm where injury has not yet been reported.

Plain-English summary

RaySearch Laboratories AB is recalling 741 units of the RayStation Radiation Therapy Treatment Planning System, Models 4.5, 4.7, and 5.0. The recall is due to an error in NVIDIA GPU card drivers that can occur in specific software configurations.

In a non-standard Citrix environment where GPU settings are configured with a virtual Citrix graphics board, an erroneous calculation may be allowed. This software is used for treatment planning and analysis of radiation therapy, providing treatment unit set-up parameters and dose distribution estimates.

The affected units were distributed nationwide to 33 states and Washington D.C. Users should contact RaySearch Laboratories for further instructions regarding the software update or correction.

The recalled product

Product
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 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 distributions expected during…
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Software
Hazard
Affected units
741

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 (12)

  • 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
  • 5.0.2.35

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Related recalls

Same manufacturer · RAYSEARCH LABORATORIES AB

See all →

Same hazard · software error

See all →

Similar recalls