Recall Z-2340-2020 — RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
U.S. FDA — Device Enforcement · Sweden · 2020-05-18 · Class II
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Reported risk: 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.
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