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

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

Corporate Office

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