FDA Device recall Z-0685-2019
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
- FDA Device
- Class II
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of I-View¿ Contrast Enhanced Digital Mammography, ASY-08109 by Hologic, citing calibration issue not possible to visualize contrast uptake in the subtracted mammography images.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0685-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-06 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hologic |
| Distribution | US |
Product
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Reason
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Identifiers
| code_info | Model Number: ASY-08109 UDI Number: 15420045512016 All units |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0685-2019%22
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