RaySearch SharePlan Software Recalled for Unexpected Import Behavior
RaySearch Laboratories is recalling SharePlan 1.1 software due to unexpected behavior when importing specific files. The issue has not caused patient mistreatment.
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 source explicitly states that the behavior has not caused patient mistreatment or other incidents, and the hazard is theoretical, placing the recall at a maximum score of 3. However, as a voluntary precautionary recall for a software documentation/behavior issue without reported harm, it fits the criteria for a Moderate (2) severity.
Plain-English summary
RaySearch Laboratories AB is recalling 20 units of SharePlan 1.1 software, also known as t-RayAutoplan version 1.2.1 (build number 1.3.1.10). The software is intended for use by clinically qualified staff, such as medical physicists and doctors, to generate and evaluate IMRT treatment plans for TomoTherapy systems.
The recall is issued because the software exhibits behavior that may be unexpected and is not clearly described in the user manual. This specific behavior occurs when importing RFA-files (.asc). The manufacturer states that this behavior has not caused patient mistreatment or other incidents.
The affected software was distributed worldwide, including in the United States (California, Kentucky, Michigan, New York, Oklahoma, Oregon, South Dakota, and Wisconsin) and internationally to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and the United Kingdom. Users must adhere to specific user actions to ensure the best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment.
The recalled product
- Product
- SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Category
- Medical Device — Software
- Affected units
- 20
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 (1)
- version 1.2.1 (build number 1.3.1.10).
Distribution
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