Horizon CiRecalls & 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
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045505827), received between Oct 22, 2025 and Oct 22, 2025 — classified as 1 injury.
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.
Reports received per month
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blister1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A HORIZON DXA SCAN OF THE HIP AND SPINE AXIAL ON (B)(6) 2025. THE USER SITE REPORTS THAT ON (B)(6) 2025, THE PATIENT CONTACTED THE USER SITE TO REPORT THAT SHE WAS BURNED BY THE DEVICE. THE USER SITE REPORTS THAT ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT STARTED TO NOTICE BLISTERING ON THE FRONT AND BACK OF THE LEGS. THE PATIENT FURTHER REPORTED TO THE USER SITE THAT ON THE EVENING OF (B)(6) 2025, THE PATIENT'S LEGS "LOCKED AND WENT NUMB." IT IS REPORTED THAT THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND SELF-MEDICATED BY PLACING HEATING PADS ON THE LEGS AND TAKING NORCO AND GABAPENTIN, WHICH THE PATIENT ALREADY HAD PRESCRIBED OUTSIDE OF THIS REPORTED EVENT. THE USER SITE REPORTS THAT DURING THE DXA SCAN ON (B)(6) 2025, THE TECHNOLOGIST NOTICED MULTIPLE ARTIFACTS IN THE HIP AND SPINE IMAGES. THE USER SITE REPORTS THAT THE PATIENT CONFIRMED THAT THEY WERE "BUCKSHOT PELLETS." THE USER SITE REPORTS THAT THE PATIENT HAS NOT CONTACTED THEM AGAIN SINCE THE INITIAL CONTACT ON (B)(6) 2025. ADDITIONALLY, THE USER SITE REPORTS THAT THEY HAVE NOT OBSERVED ANY ABNORMALITIES WITH THEIR HORIZON DXA DEVICE. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS
Patient problems: Blister
MAUDE report 23357804 ↗
Other Densitometer, bone devices
- Horizon AHologic, Inc. · Densitometer, bone1 recall3 reports
- Horizon WHologic, 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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