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