RayStation 8B Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 8B software due to errors in dose calculation algorithms that could 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 risk-of-harm product (radiation therapy software) where a dose underestimation could occur, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation 8B software (UDI # 07350002010129, Build number 8.1.0.47) used for radiation therapy and medical oncology. The recall was initiated because a software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms.
The identified error could result in a local underestimation of the expected dose during treatment administration. 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 and facilities using this software should contact RaySearch Laboratories for further instructions on how to address the software error.
The recalled product
- Product
- RayStation 8B, UDI # 07350002010129 - 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 # 07350002010129 Build number: 8.1.0.47
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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