RAYSEARCH LABORATORIES AB recalls RayStation 6 Service Pack 1, UDI #s 07350002010037, 073500
Recalled Product
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.
Hazard / Issue
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.
Issued by
FDA
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