Recall Z-0685-2019— Hologic, Inc.

Name: FDA recall Z-0685-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-06

Class II · Terminated

Class II FDA medical device recall by Hologic, Inc., initiated 2018-12-06, terminated 2020-04-24. It names one FDA 510(k) clearance: K123873. Product: I-View¿ Contrast Enhanced Digital Mammography, ASY-08109. Reason: Calibration issue not possible to visualize contrast uptake in the subtracted mammography images.

Recalling firm: Hologic, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-12-06
Terminated: 2020-04-24
Firm location: Danbury, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K123873 — CONTRAST ENHANCED DIGITAL MAMMOGRAPHYHologic, Inc.·cleared 2013-01-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.