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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.