Z-0685-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2019
- Initiation Date
- December 6, 2018
- Termination Date
- April 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