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FDADecember 6, 2018device

I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

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

The hazard

Calibration issue not possible to visualize contrast uptake in the subtracted mammography images

What to do

FDA enforcement status: Terminated

Brands named

hologic

UPCs

15420045512016

Recall history

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

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