Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

I-View¿ Contrast Enhanced Digital Mammography Recalled by Hologic, Inc. Due to Calibration issue not possible to visualize contrast uptake...

Date: December 6, 2018
Company: Hologic, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc. directly.

Affected Products

I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

Quantity: 337 units

Why Was This Recalled?

Calibration issue not possible to visualize contrast uptake in the subtracted mammography images

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hologic, Inc.

Hologic, Inc. has 18 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report