RayStation 6 Service Pack 2 Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 6 Service Pack 2 software due to a calculation error that could underestimate radiation dose.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential underestimation of radiation dose in a medical device, which poses a significant risk of harm to patients.
Plain-English summary
RaySearch Laboratories AB is recalling RayStation 6 Service Pack 2, 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 # 07350002010075 and Build number 6.2.0.7.
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 regarding the recall.
The recalled product
- Product
- RayStation 6 Service Pack 2, UDI # 07350002010075 - 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 # 07350002010075 Build number: 6.2.0.7
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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