Hologic, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0685-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

Product Classification:

Class II

Date Initiated: December 6, 2018

Date Posted: January 2, 2019

Recall Number: Z-0685-2019

Event ID: 81700

Reason for Recall:

Calibration issue not possible to visualize contrast uptake in the subtracted mammography images

Status: Terminated

Product Quantity: 337 units

Code Information:

Model Number: ASY-08109 UDI Number: 15420045512016 All units

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated