FDA Enforcement
Class II
Terminated
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Recall: Z-0685-2019
·
Reported January 2, 2019
Enforcement
- Recall Number
- Z-0685-2019
- Event ID
- 81700
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hologic, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 2, 2019
- Initiation Date
- December 6, 2018
- Classification Date
- December 27, 2018
- Termination Date
- April 24, 2020
- Address
- 36 and 37 Apple Ridge Rd, Danbury, CT, 06810-7301, United States
Description
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Reason
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Code Info
Model Number: ASY-08109 UDI Number: 15420045512016 All units
Distribution
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
Quantity
337 units