ImageChecker CAD 10.0Recalls & reported problems
Hologic, Inc. · ImageChecker® computer-aided detection is a software application intended to identify and mark regions of interest on routine screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045500037), received between Jul 25, 2024 and Jul 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Computer Software Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2024Computer Software Problem; Computer Software Problem
IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS PROCEDURE THE IMAGE CHECKER CAD FAILED TO INDICATE A REGION OF INTEREST ON A PATIENT. ON 26 JUNE THE IMAGES WERE REVIEWED AND IT WAS DETERMINED THAT THERE WAS A MASS PRESENT IN THE FATTY REGION BEHIND THE PRIMARY DENSE TISSUE ON THE RIGHT BREAST THAT WAS NOT DETERMINED. NO ADDITIONAL INFORMATION AVAILABLE AT THE MOMENT. THE CASE IS BEING INVESTIGATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19833512 ↗
Other Analyzer,medical image devices
- PowerLook AMP SLD GE US V7.2Icad, Inc. · Analyzer,Medical Image1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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