RayStation Therapy Treatment Planning System Recalled for Image Offset Errors
RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System software versions 2.0, 2.5, and 3.0 because imported medical images may be offset by one pixel, potentially leading to incorrect dose calculations.
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 where a software defect could lead to incorrect radiation dose calculations, representing a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
RaySearch Laboratories AB is recalling the RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0. This software system is designed for the treatment planning and analysis of radiation therapy. The recall affects 70 domestic units and 27 foreign units distributed in the United States and several foreign countries.
The recall was initiated because, under some circumstances, imported CT, MR, and PET images are offset from their true positions by one pixel in one or two directions. This technical error can result in incorrect dose calculations during the treatment planning process. The affected software versions are identified by build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251.
Users of the RayStation system should be aware of this information to avoid incorrect dose calculations. To determine if the version in use is affected, users should bring up the About box in the RayStation application and check the reported build number.
The recalled product
- Product
- RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
- Manufacturer
- RAYSEARCH LABORATORIES AB
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 (3)
- Software version and build numbers 2.0.0.15
- 2.5.1.89
- and 3.0.0.251 (to determine if the version used is affected
Distribution
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