FDAFebruary 5, 2021device

System INFX-8000C

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

The hazard

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

What to do

FDA enforcement status: Ongoing

Brands named

canon medical systemcanoncanon medical

Recall history

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

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