RayStation Radiation Therapy Planning Software Recalled for Calculation Error
RayStation radiation therapy planning software versions 10.0.0.1154, 10.0.1.52, and 10.0.2.10 have been recalled due to a potential calculation parameter issue that could affect treatment planning. The FDA classified this as a Class II recall affecting 213 units worldwide.
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: This Class II medical device recall involves a risk-of-harm product (radiation therapy treatment planning system) where no patient injuries have been reported and the hazard is described as potential. Per the severity rubric, risk-of-harm products without reported injury warrant a High rating.
Plain-English summary
RayStation is a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB. Versions 10.0.0.1154, 10.0.1.52, and 10.0.2.10 have been recalled due to a potential calculation parameter issue.
The FDA classified this as a Class II medical device recall. A calculation parameter in the software may exceed expected levels, potentially affecting the accuracy of radiation therapy treatment plans.
The recall affects 213 units distributed worldwide, including throughout the United States and in numerous other countries. Affected products can be identified by their serial numbers 10.0.0.1154, 10.0.1.52, and 10.0.2.10, with an expiration date of June 16, 2025.
The recalled product
- Product
- RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- treatment-planning-error
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 (7)
- UDI: 0735000201030320200526
- 0735000201036520200526 and 0735000201065520220608
- GTIN: 07350002010303
- 07350002010365 and 07350002010655
- Serial Numbers: 10.0.0.1154
- 10.0.1.52 and 10.0.2.10
- Expiration Date: 2025-06-16.
Distribution
Distributed nationwide across the United States.
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