I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Check against the official notice below — it lists the full affected range.
Hologic, Inc. is recalling 337 units of the I-View Contrast Enhanced Digital Mammography system, model number ASY-08109, nationwide and internationally due to a calibration issue that prevents visualization of contrast uptake in subtracted mammography images. The units affected include all items with UDI Number 15420045512016 and were distributed across numerous countries including the United States, Canada, Australia, and countries throughout Europe, Asia, the Middle East, and South America.
The source document does not specify a remedy or actions that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Reason for recall: Calibration issue not possible to visualize contrast uptake in the subtracted mammography images 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 Lot/code info: Model Number: ASY-08109 UDI Number: 15420045512016 All units
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.