HexaVue HexaVue-SLC 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00724995198497), received between Apr 26, 2023 and Jun 14, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT THEIR TOUCH PANEL TO THEIR HEXAVUE CUSTOM ROOM RACK WAS "FLICKERING". THE EVENT DID NOT OCCUR DURING A PATIENT PROCEDURE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25497655 ↗
• MalfunctionMay 15, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT DURING SETUP PRIOR TO THE PATIENT PROCEDURE THE TOUCH PANEL WAS UNRESPONSIVE WHILE USING THEIR HEXAVUE CUSTOM ROOM RACK. 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 25184854 ↗
• MalfunctionMay 1, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT THE MONITOR CONNECTED TO THEIR HEXAVUE CUSTOM ROOM RACK WAS DISPLAYING A DISTORTED IMAGE. THE EVENT DID NOT OCCUR DURING A PATIENT PROCEDURE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056799 ↗
• MalfunctionApr 9, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT A MONITOR CONNECTED TO THEIR HEXAVUE CUSTOM ROOM RACK WAS FLICKERING AND LOSING VIDEO. THE EVENT DID NOT OCCUR DURING A PATIENT PROCEDURE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831362 ↗
• MalfunctionMar 5, 2026Audible Prompt/Feedback Problem

  THE USER FACILITY REPORTED THAT THE AUDIO TO THEIR HEXAVUE CUSTOM ROOM RACK WAS NOT WORKING. A PROCEDURE DELAY WAS REPORTED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519760 ↗
• MalfunctionJan 5, 2026Computer Software Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE USB-X KEYBOARD EXTENDER TO THEIR HEXAVUE CUSTOM ROOM RACK WAS NOT WORKING PROPERLY AND REQUIRED A REBOOT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968062 ↗
• MalfunctionJan 5, 2026Computer Software Problem

  THE USER FACILITY REPORTED THAT THEIR HEXAVUE INTEGRATION SYSTEM WAS "LOSING FUNCTION" DURING A PATIENT PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961139 ↗
• MalfunctionAug 11, 2023Failure to Power Up; Failure to Power Up

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR HEXAVUE INTEGRATION SYSTEM LOST SIGNAL AND WOULD NOT DISPLAY THE IMAGE. USER FACILITY PERSONNEL CONNECTED THE HEXAVUE INTEGRATION SYSTEM DIRECTLY INTO THE WALL MONITOR TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17508974 ↗
• MalfunctionApr 26, 2023Failure to Power Up; Failure to Power Up

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR HEXAVUE INTEGRATION SYSTEM HAD NO POWER. THERE WAS A PROCEDURE DELAY AS USER FACILITY PERSONNEL CONNECTED THE SURGICAL EQUIPMENT DIRECTLY TO STAND ALONE MONITORS TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815242 ↗