The Recall Desk
HighFDA (Devices)·Z-1307-2014·Announced 2014-04-09

RayStation Radiation Therapy Software Recalled for Potential Dose Errors

RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software due to potential dose errors caused by program errors.

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 high-risk medical device software where potential dose errors could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

RaySearch Laboratories AB is recalling the RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5, and 4.0. This software system is designed for the treatment planning and analysis of radiation therapy. The recall involves 151 units in total, with 88 units distributed domestically in the United States and 63 units distributed internationally.

The recall is being conducted because of a potential for dose errors resulting from software program errors. The affected software versions include 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, and 4.0.2.9. The product was distributed worldwide, including in the United States and various international locations such as New Zealand, Australia, and several European and Asian countries.

Healthcare facilities and users of the RayStation system should contact RaySearch Laboratories AB for further instructions on how to address the software errors and ensure accurate treatment planning.

The recalled product

Product
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy 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 (10)

  • MODEL #(s): 2.5
  • 3.0
  • 3.5 and 4.0
  • VERSIONS: 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

Distribution

Distributed in 15 states:

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