RayStation 6 Service Pack 3 Radiation Therapy Software Recall
RaySearch Laboratories is recalling RayStation 6 Service Pack 3 software due to a calculation 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 medical device software defect that could lead to incorrect treatment dosing (underestimation), 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 6 Service Pack 3, a software product used for radiation therapy and medical oncology. 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 administered to patients. The affected software is identified by UDI # 07350002010242 and Build number 6.3.0.6.
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 RaySearch Laboratories for further instructions on how to address the calculation error.
The recalled product
- Product
- RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Manufacturer
- RAYSEARCH LABORATORIES AB
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 # 07350002010242 Build number: 6.3.0.6
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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