The Recall Desk
ModerateFDA (Devices)·Z-0079-2017·Announced 2016-10-19

RaySearch Radiation Therapy Treatment Planning System Software Recall

RaySearch Laboratories is recalling Model 5.0 software due to a bug that may display incorrect dose statistics in treatment plan reports.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a software display error that may lead to incorrect documentation of dose statistics, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

RaySearch Laboratories AB is recalling the Radiation Therapy Treatment Planning System, Model 5.0. The recall involves 491 units, with 187 distributed domestically in Arizona, California, Florida, Montana, North Carolina, New York, Texas, Ohio, and Washington, and 304 units distributed internationally.

The recall is due to a software error in the report generation feature. For treatment plans consisting of multiple beam sets, the table for ROI plan dose statistics may incorrectly display statistics for a beam set dose instead of the plan dose. This error is triggered only when using a specific report template where beam set dose statistics are included as the last dose statistics prior to the plan dose statistics.

Healthcare providers using this software should verify their report templates and consult the manufacturer for guidance on correcting the display error to ensure accurate treatment planning documentation.

The recalled product

Product
Radiation Therapy Treatment Planning System, Model 5.0
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 (2)

  • 5.0.0.37
  • 5.0.1.11 and 5.0.2.35

Distribution

Distributed in 9 states:

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