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FDAFebruary 10, 2020device

AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications

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

The hazard

Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.

What to do

FDA enforcement status: Terminated

Brands named

agfa n vagfa

Recall history

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

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