MalfunctionKGI
HORIZON
Received Oct 23, 2025 · Event occurred Oct 2, 2025
Report 3005496266-2025-00077 · MDR key 23368067
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 DURING A HORIZON PROCEDURE ON (B)(6) 2025, THE TECHNOLOGIST RECEIVED AN ELECTROSTATIC DISCHARGE (ESD) WHEN PRESSING A BUTTON ON THE CONTROL PANEL, AND THE SYSTEM SHUT DOWN. A SECOND STAFF MEMBER AT THE USER SITE REPORTS THAT THEY DID NOT EXPERIENCE ANY SHOCKS WHEN TOUCHING THE BUTTONS ON THE CONTROL PANEL. A HOLOGIC TECHNICAL SUPPORT (TS) AGENT CONTACTED THE USER SITE TO INQUIRE ABOUT THE STATUS OF THE REPORTED PROBLEM. THE USER SITE REPORTED TO TS THAT THE HORIZON DEVICE IS FUNCTIONAL. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME.