Harmony iQ Harmony iQ 2800Recalls & reported problems
Black Diamond Video, Inc. · The Surgical Light Control and Surgical Camera Control for the Harmony IQ 2800 Integration Systems promotes efficient and prompt reaction to procedure events. · Class 2
All models of Harmony iQ (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995199135), received between Mar 10, 2023 and Sep 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Display or Visual Feedback Problem2
- Intermittent Loss of Power1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, 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 ↗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 ↗MalfunctionMar 10, 2023Intermittent Loss of Power; Intermittent Loss of Power
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THAT THE SURGICAL LIGHT TO THEIR HARMONY IQ 2800 INTEGRATION SYSTEM TURNED OFF THEN ON WITHOUT BEING COMMANDED. THE LIGHTS WERE IMMEDIATELY MANUALLY TURNED BACK ON WITH THE SURGICAL WALL CONTROL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16522786 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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