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FDAMarch 1, 2021device

ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

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

The hazard

In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.

What to do

FDA enforcement status: Terminated

Brands named

brainlab agbrainlab

UPCs

04056481142315

Recall history

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

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ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). — Recall Details · AllClear