RayStation 9B Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 9B software due to a dose calculation error that could underestimate radiation therapy doses.
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 risk-of-harm product (radiation therapy software) where a dose underestimation could lead to treatment failure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation 9B software, identified by UDI # 07350002010266 and build number 9.1.0.933. This software is used for radiation therapy and medical oncology to administer treatments. The recall is due to a software error identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms.
The error could result in a local underestimation of the expected dose during treatment. The affected software was 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.
Healthcare providers using this software should contact RaySearch Laboratories for further instructions on how to address the dose calculation error.
The recalled product
- Product
- RayStation 9B, UDI # 07350002010266 - 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 (1)
- UDI # 07350002010266 Build number: 9.1.0.933
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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