Hologic, Inc. recalls I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
- Recall date
- December 6, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0685-2019
- FDA classification
- Class II
- Brand / firm
- Hologic, Inc.
- Sold / distributed
- 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 Switzerlan…
Why it was recalled
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Get recall alerts
Free email alert whenever Hologic, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Hologic, Inc.