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FDAMay 18, 2020device

RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

raysearch laboratories abraysearchraysearch laboratories

UPCs

07350002010020

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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