RayStation 8B Service Pack 1 Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 8B Service Pack 1 due to a software error 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 injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation 8B Service Pack 1 (UDI # 07350002010204, Build number 8.1.1.8). This software is used for radiation therapy and medical oncology to administer treatments.
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.
The product 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. Users of this software should contact the manufacturer for further instructions.
The recalled product
- Product
- RayStation 8B Service Pack 1, UDI # 07350002010204 - 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 # 07350002010204 Build number: 8.1.1.8
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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