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MULTIVIEWRecalls & reported problems

Hologic, Inc. · MultiView™ is a software application that provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis. · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045504684), received between Nov 3, 2017 and Nov 3, 2017 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 3, 2017Adverse Event Without Identified Device or Use Problem

    ON OCT. 11, 2017, CUSTOMER REPORTED THAT DURING A BIOPSY PROCEDURE THE PATIENT HAD A RUPTURE OF THE GEL SILICONE IMPLANT. WE WERE UNABLE TO OBTAIN ADDITIONAL INFORMATION.

    Patient problems: Foreign Body In Patient

    MAUDE report 7000457 ↗

Other System, image processing, radiological devices

All System, image processing, radiological devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.