Recall – Calibration Issue

Company: Hologic, Inc.
Date of Enforcement Report: 12/27/2018
Class II

PRODUCT

I-View Contrast Enhanced Digital Mammography, ASY-08109

Recall Number: Z-0685-2019

REASON

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

RECALLING FIRM/MANUFACTURER

Hologic, Inc., Danbury, CT on 12/6/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
337 units

DISTRIBUTION
Nationwide and Internationally

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