RayStation Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation software versions 4.0 to 5.0 Service Pack 2 due to a dose calculation error that may underestimate radiation dose.
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 error that could lead to incorrect radiation dosing, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation software versions 4.0 through 5.0 Service Pack 2. This software is used for radiation therapy and medical oncology to administer treatments. The recall covers specific build numbers distributed nationwide in the United States, including in Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
The recall was initiated because a software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms. This error could result in a local underestimation of the expected dose during treatment planning.
Healthcare providers and facilities using these specific versions of RayStation software should contact RaySearch Laboratories for further instructions on how to address the software error.
The recalled product
- Product
- RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- 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 (9)
- Build numbers: 4.0.3.4
- 4.5.1.14
- 4.7.2.5
- 4.7.3.13
- 4.7.4.4
- 4.7.5.4
- 4.7.6.7
- 5.0.1.11
- 5.0.2.35
Distribution
Part of a larger recall action
This product is one of 15 recalled by RAYSEARCH LABORATORIES AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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