I-View Contrast Enhanced Digital Mammography, ASY-08109
- Company
- Hologic, Inc.
- Recall Initiated
- December 6, 2018
- Terminated
- April 24, 2020
- Recall Number
- Z-0685-2019
- Quantity
- 337 units
- Firm Location
- Danbury, CT
Reason for Recall
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Distribution
Nationwide Foreign: Australia Austria Belgium Brazil Canada China Colombia Ecuador Egypt France Germany Greece Hong Kong India Ireland Israel Italy Japan Korea, Republic of Kuwait Malaysia Mexico Netherlands Pakistan Peru Poland Portugal Saudi Arabia Singapore Slovakia South Africa Spain Switzerland Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom
Lot / Code Info
Model Number: ASY-08109 UDI Number: 15420045512016 All units
Root Cause
Software design
Action Taken
Hologic issued letter on 12/6/2018 USPS Certified Mail to customers to inform them of this product correction, and Hologic asks customers to only use I-View for patients with known lesions and confirm the image quality is of acceptable diagnostic quality.Hologic will scheduling appointments to recalibrate the systems for contrast enhanced digital mammography.