Hologic, Inc. recalls I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

Recalled January 2, 2019 · FDA recall Z-0685-2019 · Hologic

Hazard

Calibration issue not possible to visualize contrast uptake in the subtracted mammography images · FDA Class II

Units

337 units

Sold at

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

Description

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

Product

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

Manufacturer(s)

Hologic, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →