RayStation 8A, UDI # 07350002010112 - 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 8A is software used in radiation therapy and medical oncology to plan and administer cancer treatments. A software error has been identified in the Pencil Beam Scanning and Line Scanning dose calculation algorithms that could cause the software to underestimate radiation doses in certain areas of treatment. The affected software, identified by UDI # 07350002010112 and Build number 8.0.0.61, 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 recall record does not specify what remedy affected consumers or healthcare facilities should take.
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 # 07350002010112 Build number: 8.0.0.61
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.