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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.