MAUDE Adverse Event Report: HOLOGIC, INC HORIZON; DENSITOMETER, BONE

Model Number	HORIZON-A
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
Event or Problem Description
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 tested the switches to ensure proper functionality and noted that the connector for a switch under the front of the table had some loose pins.The fse reseated the pins, retested the system and confirmed the system is functioning in accordance with manufacturer specifications.No further information is currently available.
Additional Manufacturer Narrative
Additional information was received, a reassessment of reportability was completed, and it was determined that this and similar events are no longer considered reportable.Due to the hologic field service engineers (fse) inability to reproduce the user reported "static shock," a definitive determination could not be made whether the reported shock was related to electrostatic discharge (esd) or the horizon device.Therefore, out of an abundance of caution, a malfunction mdr was submitted on october 21, 2025.However, additional information has been received, in which the same user site reported another esd for the same horizon device on december 1, 2025.Upon awareness of the most recent report, a hologic field service engineer (fse) was dispatched to examine the device on december 2, 2025.During this examination, the fse "inspected the incoming power 119.8 vac neutral to ground 314.9 mv with unit plugged in, neutral to ground 54 mv with unit unplugged, removed the covers and checked that all grounds were tight and secured.Measurements were made from ground to various spots on the unit while engaging motors to move the c-arm, table, and raise the pedestals.There was no floating voltage present." after completion of the device examination, the hologic fse found the system functioning as intended and meets manufacturer specifications.Results were within acceptable ranges; therefore, this and similar events are no longer considered reportable by hologic.

• Brand Name: HORIZON
• Common Device Name: DENSITOMETER, BONE
• Manufacturer (Section D): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer (Section G): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23350701
• Report Number: 3005496266-2025-00076
• Device Sequence Number: 20785427
• Product Code: KGI
• UDI-Device Identifier: 15420045505384
• UDI-Public: (01)15420045505384(11)250607
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K023398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HORIZON-A
• Device Catalogue Number: HORIZON-A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown