RayStation 9A, UDI # 07350002010174 - 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 9A (UDI # 07350002010174, Build number 9.0.0.113), a software system 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 local underestimation of expected radiation dose during treatment.
The affected software has been distributed nationwide across the United 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 action affected consumers or healthcare facilities should take in response to 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 # 07350002010174 Build number: 9.0.0.113
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.