RayStation 7 Software Recalled for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 7 software due to errors in dose calculation algorithms 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 defect that could lead to incorrect radiation dosing, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation 7 software, identified by UDI # 07350002010068 and Build number 7.0.0.19. 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 during treatment planning.
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 resolving the issue.
The recalled product
- Product
- RayStation 7, UDI # 07350002010068 - 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 # 07350002010068 Build number: 7.0.0.19
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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