MalfunctionKGI
HORIZON
Received Nov 10, 2025 · Event occurred Oct 20, 2025
Report 3005496266-2025-00093 · MDR key 23514536
Device
Product problems
- Unintended Electrical Shock
- Unintended Electrical Shock
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE USER SITE THAT PRIOR TO A HORIZON PROCEDURE ON (B)(6) 2025, A TECHNOLOGIST RECEIVED AN ELECTROSTATIC DISCHARGE (ESD) WHEN PRESSING A CONTROL PANEL BUTTON. THE USER SITE ALSO REPORTED THAT THE CONTROL PANEL SHUT DOWN AFTER THE ESD. NO INJURIES WERE REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE SYSTEM AND COULD NOT REPRODUCE THE ESD. T HE FSE REPLACED THE CONTROL PANEL OF THE DEVICE AND VERIFIED THAT THE SYSTEM IS NOW OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME.