Harmony iQRecalls & reported problems across all models
Black Diamond Video, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Harmony iQ by Black Diamond Video, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2023 and Sep 30, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Harmony iQ problems
Device problems
- Display or Visual Feedback Problem21
- Electrical /Electronic Property Problem1
- Intermittent Loss of Power1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
Harmony iQ models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Harmony iQ Harmony iQ 3600Light, surgical, accessories20 reports
- Harmony iQ Harmony iQ 2800Light, surgical, accessories3 reports
Recent Harmony iQ adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Display or Visual Feedback Problem
The user facility reported that the monitor connected to their Harmony iQ Integration System was frozen on a video display. This event did not occur during a patient procedure. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946345 ↗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 ↗MalfunctionAug 27, 2026Display or Visual Feedback Problem
The user facility reported that the monitors connected to their Harmony iQ Integration System were flickering. This event did not occur during a patient procedure. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480041 ↗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 ↗
Other Black Diamond Video, Inc. products
All Black Diamond Video, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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