RayStation 7, UDI # 07350002010068 - 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 7 (UDI # 07350002010068, Build number 7.0.0.19), a software system used in radiation therapy and medical oncology to administer treatments. The recall was initiated due to a software error identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected radiation dose. The affected software 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 a remedy or recommended action for affected consumers to 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 # 07350002010068 Build number: 7.0.0.19
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.