RayStation Radiation Therapy Software Recalled for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software due to an issue with photon dose calculation for Dynamic MLC plans.
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 medical device software defect that could lead to incorrect radiation dose calculations, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
RaySearch Laboratories AB is recalling the RayStation Radiation Therapy Treatment Planning System software, specifically versions 3.5, 4.0, 4.5, and 4.7. The recall involves 245 domestic units distributed nationwide. The affected software is used for treatment planning and analysis of radiation therapy.
The recall is due to an issue with photon dose calculation for Dynamic MLC (DMLC) plans on machines where the MLC is positioned above the jaws, such as some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and the individual DMLC plan characteristics. For RayStation 4.7, the issue applies to machines with fixed jaws regardless of MLC/jaw position.
Healthcare providers using this software should contact RaySearch Laboratories for further instructions on how to address the dose calculation issue.
The recalled product
- Product
- RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for t
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- Affected units
- 245
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)
- Build numbers 3.5.0.16
- 3.5.1.6
- 4.0.0.14
- 4.0.1.4
- 4.0.2.9
- 4.0.3.4
- 4.5.0.19
- 4.5.1.14 and 4.7.0.15
Distribution
Distributed nationwide across the United States.
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