Vividimage 4K RLM314K2Recalls & reported problems

Black Diamond Video, Inc. · The Vividimage 31-inch 4K Surgical Display, Generator 2, is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception. · Class 1

All models of Vividimage 4K (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 20
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00724995195106), received between Mar 6, 2024 and Sep 23, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (20 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Display or Visual Feedback Problem20

Patient problems

No Clinical Signs, Symptoms or Conditions20

Recent adverse event reports

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

MalfunctionSep 23, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874093 ↗
MalfunctionJul 27, 2026Display or Visual Feedback Problem
The user facility reported that during a patient procedure their Vividimage Surgical Monitor was flashing/blinking. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005051 ↗
MalfunctionJun 17, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE SURGICAL MONITORS WERE FLICKERING AND A "NOISE IS COMING FROM THE POWER CABINET." NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536044 ↗
MalfunctionJun 17, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THE DISPLAY TO THEIR VIVIDIMAGE SURGICAL MONITORS IS BLANK. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535996 ↗
MalfunctionJun 17, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE SURGICAL MONITORS WERE FLICKERING AND A "BUZZING NOISE IS COMING FROM THE POWER CABINET." NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535976 ↗
MalfunctionJun 17, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE SURGICAL MONITORS WERE FLICKERING AND ONE OF THEM WAS MAKING A "BUZZING NOISE IS COMING FROM THE POWER SUPPLY." NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535800 ↗
MalfunctionJun 17, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE SURGICAL MONITORS WERE FLICKERING AND ONE OF THEM WAS MAKING A "BUZZING NOISE IS COMING FROM THE POWER SUPPLY." NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535734 ↗
MalfunctionJun 17, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE SURGICAL MONITOR FLICKERS AND "A NOISE IS COMING FROM THE POWER SUPPLY." NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535614 ↗
MalfunctionJun 17, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE SURGICAL MONITOR WAS "FLOATING IN MIDDLE OF PROCEDURE". NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535529 ↗
MalfunctionJun 17, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE SURGICAL MONITOR WAS FLICKERING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535399 ↗
MalfunctionJun 16, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES THEIR VIVIDIMAGE SURGICAL MONITOR WAS FLASHING AND FLICKERING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25527622 ↗
MalfunctionJun 11, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE 4K SURGICAL DISPLAY MONITORS WERE FLICKERING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25472770 ↗
MalfunctionJun 5, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES THE MONITOR TO THEIR VIVIDIMAGE 4K SURGICAL DISPLAY WAS FLICKERING. THE PROCEDURES WERE COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410837 ↗
MalfunctionJun 5, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT PRIOR TO A PATIENT PROCEDURE THE MONITOR TO THEIR VIVIDIMAGE 4K SURGICAL DISPLAY WAS SHOWING LINES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25409335 ↗
MalfunctionJun 5, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT PRIOR TO A PATIENT PROCEDURE THE MONITOR TO THEIR VIVIDIMAGE 4K SURGICAL DISPLAY WOULD NOT TURN ON. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25409214 ↗
MalfunctionApr 16, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE 4K SURGICAL DISPLAY MONITOR WAS FLICKERING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905282 ↗
MalfunctionApr 16, 2026Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE 4K SURGICAL DISPLAY MONITOR HAD LINES IN THE IMAGE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899921 ↗
MalfunctionJun 28, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE USER FACILITY REPORTED THAT THEIR VIVIDIMAGE 4K SURGICAL DISPLAY IS POWERED BUT DOES NOT DISPLAY IMAGE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19634180 ↗
MalfunctionMar 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO SWISSMEDIC THAT OPERATING ROOM 07 WAS PREPARED FOR UROLOGICAL SURGERY UNDER VIDEOSCOPY USING REMOTE SCREENS FROM THE STERIS INTEGRATION SYSTEM AND SCREEN NUMBER 02 COULD NOT BE USED. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18851280 ↗
MalfunctionMar 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO SWISSMEDIC THAT DURING A VIDEO-SCOPED OPERATION USING THE STERIS INTEGRATION SYSTEM, THE SCREENS IN OPERATING ROOM NO. 04 BEGAN TO FLASH RANDOMLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18850847 ↗

Device details

UDI-DI	`00724995195106`
Brand	Vividimage 4K
Model	RLM314K2
Company	Black Diamond Video, Inc.
Product code	KQM · CAMERA, SURGICAL AND ACCESSORIES
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 3, 2024

Device type (GMDN): Image display unit, colour

An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.

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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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