Horizon WRecalls & reported problems
Hologic, Inc. · The Horizon® Dual-Energy X-Ray Absorptiometry (DXA) System is a computer-assisted X-Ray scanner used to aid a physician in measuring bone mineral density (BMD), determining fracture risk, and estimating the lean body mass and fat mass of non-osseous tissues. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045505834), received between Nov 22, 2017 and Nov 22, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Recalls naming this device
- Jun 13, 2024Open, Classified
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.
Z-2373-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Displays Incorrect Message1
- Poor Quality Image1
Patient problems
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2017Poor Quality Image; Device Displays Incorrect Message; Poor Quality Image; Device Displays Incorrect Message
IT WAS REPORTED THAT AFTER THEY WERE GETTING ERRORS DURING A SCAN, CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THE DETECTOR NEEDED TO BE REPLACED. ONCE THIS WAS DONE THE SYSTEM IS WORKING AS INTENDED.
Patient problems: Not Applicable
MAUDE report 7052987 ↗
Other Densitometer, bone devices
- Horizon AHologic, Inc. · Densitometer, bone1 recall3 reports
- Horizon CiHologic, Inc. · Densitometer, bone1 recall1 report
- Horizon CHologic, Inc. · Densitometer, bone1 recall0 reports
- Horizon WiHologic, Inc. · Densitometer, bone1 recall0 reports
- Discovery WiHologic, Inc. · Densitometer, bone5 reports
- Prodigy F2GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC · Densitometer, bone1 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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