Harmony iQ Harmony iQ 3600Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00724995199142), received between Mar 6, 2024 and Sep 17, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (19 reports).

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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810284 ↗
• MalfunctionSep 17, 2026Display or Visual Feedback Problem

  The user facility reported that the monitor connected to their HarmonyIQ 3600 Integration System is flickering. No report of patient or procedure involvement. No report of injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804105 ↗
• MalfunctionSep 17, 2026Display or Visual Feedback Problem

  The user facility reported that the monitors connected to their HarmonyIQ 3600 Integration System are flickering. No report of patient or procedure involvement. No report of injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804019 ↗
• MalfunctionSep 9, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698102 ↗
• MalfunctionApr 30, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT THE VIDEO WAS NOT ROUTING TO THE MONITOR OF THEIR HARMONY IQ INTEGRATION SYSTEM RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25053637 ↗
• MalfunctionApr 24, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE, AN EMPLOYEE ATTEMPTED TO ROUTE A VIDEO CONNECTION TO THE HARMONY IQ SYSTEM USING A VIDEO CONVERTER AND THE VIDEO SOURCE DID NOT DISPLAY ON THE MONITOR. THE EMPLOYEE USED A DIFFERENT VIDEO CONVERTER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984721 ↗
• MalfunctionApr 9, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TOUCHSCREEN TO THEIR HARMONY IQ INTEGRATION SYSTEM WENT BLANK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829279 ↗
• MalfunctionApr 2, 2026Display or Visual Feedback Problem

  A STERIS SERVICE TECHNICIAN REPORTED OBSERVING FLICKERING ON THE MONITORS ATTACHED TO THE USER FACILITY'S HARMONY IQ INTEGRATION SYSTEM. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766448 ↗
• MalfunctionMar 12, 2026Electrical /Electronic Property Problem

  THE USER FACILITY REPORTED THAT THEIR HARMONY IQ3600 INTEGRATION SYSTEM UNIT REBOOTED WITHOUT COMMAND DURING A PATIENT PROCEDURE CAUSING A SHORT PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580593 ↗
• MalfunctionMar 6, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT THERE WAS NO VIDEO INPUT TO THE MONITOR WHILE USING THEIR HARMONY IQ3600 INTEGRATION SYSTEM. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532903 ↗
• MalfunctionMar 6, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT AT THE START OF A PATIENT PROCEDURE THERE WAS A LOSS OF VIDEO INPUT WHILE USING THEIR HARMONY IQ3600 INTEGRATION SYSTEM. THE PROCEDURE WAS MOVED TO A DIFFERENT ROOM RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530794 ↗
• MalfunctionFeb 26, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT THEIR SURGICAL DISPLAY SCREEN DOES NOT WORK AND STARTS "FLASHING". NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469771 ↗
• MalfunctionFeb 19, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT THEIR SURGICAL DISPLAY SCREEN "TURNED BLACK" DURING A PATIENT PROCEDURE WHILE USING THEIR HARMONY IQ INTEGRATION SYSTEM RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412481 ↗
• MalfunctionJan 3, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT THEIR SURGICAL SCREENS WERE FLICKERING DURING A PATIENT PROCEDURE WHILE USING THEIR HARMONY IQ INTEGRATION SYSTEM. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066941 ↗
• MalfunctionJun 28, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT THEIR HARMONY IQ INTEGRATION SYSTEM WAS FROZEN AND HAD TO BE RESTARTED. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634127 ↗
• MalfunctionApr 18, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT THE SCREENS TO THEIR HARMONY IQ INTEGRATION SYSTEM SWITCHED OFF DURING A PATIENT PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130811 ↗
• MalfunctionApr 18, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT THEIR SCREEN WAS "DEFECTIVE". NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130547 ↗
• MalfunctionMar 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO SWISSMEDIC THAT WHILE USING THE ARTHREX ARTHROSCOPY TOWER WITH IMAGE TRANSFER TO THE REMOTE SCREENS OF THE STERIS INTEGRATION SYSTEM, THE 02 SCREENS REPEATEDLY SWITCH OFF AND ON. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851916 ↗
• MalfunctionMar 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO SWISS MEDIC THAT A UROLOGICAL SURGERY WAS PERFORMED IN OPERATING ROOM 06 OF THE OPERATING THEATRE USING THE STORZ UROLOGY TOWER WITH IMAGE TRANSFER TO THE REMOTE SCREENS OF THE STERIS INTEGRATION SYSTEM. DURING USE, THE 02 SCREENS REPEATEDLY SWITCH OFF AND ON. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851842 ↗
• MalfunctionMar 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO SWISS MEDIC THAT DURING A BARIATRIC SURGERY PERFORMED IN OPERATING ROOM 8 WITH IMAGE TRANSFER TO STERIS SCREENS FROM THE STORZ TOWER, THE 02 STERIS SCREENS REPEATEDLY SWITCHED OFF AND ON. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851621 ↗