FDAMarch 21, 2022device

ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

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

The hazard

Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location

What to do

FDA enforcement status: Completed

Brands named

varian medical systems imaging laboratoryvarianvarian medical

UPCs

008561000060660085610000608000856100006097008561000061100085610000612700856100006165

Recall history

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

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