The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1481-2014·Announced 2014-04-30

RaySearch Ray Station Software Recalled for Dose Miscalculations

RaySearch Laboratories is recalling Ray Station software versions 2.0 through 4.0 due to dose miscalculations for support structures on CT images.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the potential for significant injury due to radiation dose miscalculations.

Plain-English summary

RaySearch Laboratories AB has initiated a Class II recall for the RaySearch Ray Station Radiation Therapy Treatment Planning System, a stand-alone software product. The recall affects versions 2.0, 2.5, 3.0, 3.5, and 4.0.

The recall was issued because the software may miscalculate radiation doses for bolus, external, or fixation support structures when processing CT images. This defect could impact the accuracy of treatment planning for radiation therapy.

A total of 251 units are affected, with 148 units distributed domestically in the United States and 103 units distributed internationally. The software was distributed worldwide, including in the United States and various countries in Europe, Asia, and Oceania. Users of the affected software should contact RaySearch Laboratories for further instructions regarding the recall and potential corrective actions.

The recalled product

Product
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
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 (8)

  • Versions: 2.0.0.15
  • 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 nationwide across the United States.

The notice also names 17 states specifically:

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