RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - 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 has recalled RayStation 6 Service Pack 1 (UDI #s 07350002010037 and 07350002010082, Build number 6.1.1.2), software used for radiation therapy and medical oncology treatment planning. A 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. The affected software was distributed nationwide across the United States, including in Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
The source document does not specify a remedy or corrective action for affected consumers.
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 #s 07350002010037, 07350002010082 Build number: 6.1.1.2
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.