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I -View™ Contrast Enhanced Digital Mammography ASY-08109Recalls & reported problems

Hologic, Inc. · I-View · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Dec 6, 2018Class IITerminated

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

    Z-0685-2019 · Root cause: Software design · Recall details · FDA record ↗

Other Full field digital, system, x-ray, mammographic devices

All Full field digital, system, x-ray, mammographic devices →

Sources and updates

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