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

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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