Z-0685-2019 Class II Terminated
FDA device recall Z-0685-2019 was initiated by Hologic, Inc. on Dec 6, 2018 and is designated Class II. Reason for recall: Calibration issue not possible to visualize contrast uptake in the subtracted mammography images The recall status is terminated (terminated Apr 24, 2020). Affected quantity: 337 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 2, 2019
- Initiation Date
- Dec 6, 2018
- Termination Date
- Apr 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 337 units
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
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
Code Information
Model Number: ASY-08109 UDI Number: 15420045512016 All units
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0685-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026