RayStation 8B Service Pack 1, UDI # 07350002010204 - 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.
RayStation 8B Service Pack 1, a software system used for radiation therapy and medical oncology treatment planning and administration, has been recalled due to a software error identified in its Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms. This error could result in a local underestimation of the expected radiation dose. The affected software (UDI # 07350002010204, Build number 8.1.1.8) was 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 source document does not specify a remedy or recommended 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 # 07350002010204 Build number: 8.1.1.8
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.