Horizon ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15420045505384), received between Nov 7, 2017 and Oct 21, 2025 — classified as 1 injury, 2 malfunctions.

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

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED BY THE USER SITE THAT THE HORIZON SYSTEM HAS HAD ISSUES WITH INTERMITTENT SHUTDOWNS AND ONE TECHNOLOGIST REPORTED RECEIVING AN ELECTROSTATIC DISCHARGE (ESD) WHILE PRESSING A CONTROL PANEL BUTTON ON (B)(6) 2025. THE USER SITE REPORTS THAT NO PATIENT WAS PRESENT AT THE TIME OF THE REPORTED ESD AND THE TECHNOLOGIST DID NOT REQUIRE ANY MEDICAL INTERVENTION. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE SYSTEM AND COULD NOT REPRODUCE THE ESD BUT DID FIND THAT THE FRONT TABLE TAPE STRIP WAS NOT FUNCTIONING PROPERLY. THE FSE ORDERED A REPLACEMENT CONTROL PANEL AND TAPE STRIP. A SECOND HOLOGIC FSE WAS LATER DISPATCHED TO COMPLETE THE CONTROL PANEL AND TAPE STRIP REPLACEMENT AT WHICH POINT ADDITIONAL INFORMATION WAS OBTAINED FROM THE USER SITE. THE FSE REPORTS THAT THE USER INDICATED THAT THE INTERMITTENT SHUTDOWNS ARE OCCURRING WHEN PATIENTS GET ON/OFF THE TABLE, THE SYSTEM SHUTS DOWN FOR APPROXIMATELY 5 SECONDS AND THEN AUTOMATICALLY RESTARTS WITH NO ERROR CODES DISPLAYING AND NO ENTRIES IN THE ERROR LOG. THE FSE REPLACED THE CONTROL PANEL, TESTED THE SYSTEM AND DID NOT OBSERVE ANY SHUTDOWNS OR OTHER ANOMALIES. WHILE TESTING THE SYSTEM, THE FSE ALSO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350701 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OCTOBER 12TH, IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOSS OF SUCTION DURING A PROCEDURE, AND MULTIPLE ATTEMPTS TO REACH OUT FOR ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS. THE CUSTOMER REPORTED INITIALLY THAT A PATIENT SAFETY REPORT WAS BEING SUBMITTED. NO ADDITIONAL INFORMATION ON THE SAFETY REPORT COULD BE OBTAINED. HOLOGIC IS SUBMITTING THIS REPORT IN AN ABUNDANCE OF CAUTION.

  Patient problems: Insufficient Information

  MAUDE report 18116091 ↗
• MalfunctionNov 7, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AFTER SCAN THE FILE FAILED TO OPEN, CAUSING THE PATIENT TO BE RE-EXPOSED. RESTARTING THE SYSTEM RESOLVE THE ISSUE.

  Patient problems: Not Applicable

  MAUDE report 7006817 ↗