RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Check against the official notice below — it lists the full affected range.
RaySearch Laboratories AB is recalling RayStation 9B, a software system used for radiation therapy and medical oncology treatment planning and administration. A software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in underestimation of radiation dose in localized areas. The affected software has Build number 9.1.0.933 and has been distributed nationwide across multiple states including Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
The recall record does not specify a remedy or recommended action for consumers or healthcare facilities affected by this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Reason for recall: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. Distribution: US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana. Quantity: N/A Lot/code info: UDI # 07350002010266 Build number: 9.1.0.933
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.