EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Recalls & reported problems

Olympus Medical Systems Corp. · CV-190 EVIS EXERA III VIDEO PROCESSOR · Class 2

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Olympus EVIS EXERA III video processor is an accessory for endoscopes. Reports mostly describe no image on the screen, poor or flickering pictures, connection problems, and unresponsive buttons. There are 7,621 reports, with no deaths and 61 injuries. One open recall, begun in September 2023, covers some units that do not start up properly because of out-of-spec power supply parts.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 7,688
Deaths reported: 0
Injuries reported: 61
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 7,688 adverse event reports that list this exact device (DI 04953170298622), received between Apr 3, 2020 and Sep 30, 2026 — classified as 61 injuries, 7,627 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3,834 reports).

1 FDA recall record name this device's identifier, 1 still open.

17 other recalls cover devices cleared under the same FDA submission (K121959, K123365, K131780); they may or may not involve this specific model.

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.

Recalls naming this device

Sep 14, 2023Class IIOpen, Classified
Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
Z-0056-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Device problems

No Display/Image3,834
Communication or Transmission Problem1,583
Poor Quality Image513
Erratic or Intermittent Display385
Connection Problem250
Electrical /Electronic Property Problem229
Failure to Power Up164
Output Problem159

Patient problems

No Clinical Signs, Symptoms or Conditions7,245
No Consequences Or Impact To Patient270
No Patient Involvement186
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Hemorrhage/Blood Loss/Bleeding3
Insufficient Information3
No Information3
Patient Problem/Medical Problem3

Recent adverse event reports

The 25 most recent of 7,688 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026No Display/Image; Connection Problem
It was reported that the video board had failed, resulting in the device not being Electrosurgical ESU compatible and preventing connection of a pigtail for compatibility. There were no reports of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951385 ↗
MalfunctionSep 29, 2026Communication or Transmission Problem; Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937618 ↗
MalfunctionSep 29, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935763 ↗
MalfunctionSep 29, 2026No Display/Image
The customer reported no image during inspection for use involving an Olympus Video system center. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934865 ↗
MalfunctionSep 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934714 ↗
MalfunctionSep 29, 2026Communication or Transmission Problem
The customer reported the video system center unsupported scope errors during inspection for use. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934486 ↗
MalfunctionSep 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934485 ↗
MalfunctionSep 29, 2026Output Problem
The customer reported that the device was not capturing during inspection for use involving an Olympus Video System Center. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934235 ↗
MalfunctionSep 29, 2026Erratic or Intermittent Display
The customer reported the live feed flickers in and out on the image capture machine during Inspection for use involving an Olympus video system center. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927294 ↗
MalfunctionSep 28, 2026No Display/Image
The customer reported no image during Colonoscopy Diagnostic procedure while the patient was under sedation involving an Olympus video system center. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921622 ↗
MalfunctionSep 28, 2026Communication or Transmission Problem
The customer reported that the device began displaying the error message Unsupported scope during inspection for use, involving an Olympus Video System Center. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913362 ↗
MalfunctionSep 25, 2026No Display/Image
The customer reported cannot capture images during Inspection for use involving an Olympus video system center. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899647 ↗
MalfunctionSep 25, 2026Unexpected Shutdown
The customer reported that the device would not stay on, involving an Olympus Video System Center. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896373 ↗
MalfunctionSep 25, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892639 ↗
MalfunctionSep 25, 2026Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892579 ↗
MalfunctionSep 25, 2026No Display/Image; Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892570 ↗
MalfunctionSep 24, 2026No Device Output; Overheating of Device; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892289 ↗
MalfunctionSep 24, 2026Erratic or Intermittent Display
The customer reported that the image was flashing on and off while using the Olympus video system center. The issue occurred during an unspecified procedure that was able to be completed using the same device. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885877 ↗
MalfunctionSep 23, 2026No Display/Image
The customer reported black image during inspection for use involving an Olympus video system center. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866981 ↗
MalfunctionSep 23, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862958 ↗
MalfunctionSep 22, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861347 ↗
MalfunctionSep 22, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859869 ↗
MalfunctionSep 21, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848556 ↗
MalfunctionSep 21, 2026No Display/Image; Communication or Transmission Problem
The customer reported the video system center had Communication error B30 and no image during Inspection for use. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842365 ↗
MalfunctionSep 18, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829284 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121959, K123365, K131780. One submission often covers many models, so check the product and lot details in each record.

Z-0053-2026 · Sep 11, 2025 · Open, Classified
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Z-0050-2026 · Sep 11, 2025 · Open, Classified
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
Z-0049-2026 · Sep 11, 2025 · Open, Classified
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
Z-0063-2026 · Sep 11, 2025 · Open, Classified
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
Z-0060-2026 · Sep 11, 2025 · Open, Classified
BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
Z-1210-2024 · Jan 11, 2024 · Open, Classified
Colonoscope, Model Number PCF-H190DL.
Z-0415-2024 · Oct 16, 2023 · Open, Classified
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Z-0417-2024 · Oct 16, 2023 · Open, Classified
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Z-0416-2024 · Oct 16, 2023 · Open, Classified
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Z-0419-2024 · Oct 16, 2023 · Open, Classified
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Z-0418-2024 · Oct 16, 2023 · Open, Classified
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Z-0192-2024 · Oct 12, 2023 · Open, Classified
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
Z-0327-2024 · Sep 25, 2023 · Open, Classified
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190
Z-0341-2024 · Sep 25, 2023 · Open, Classified
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-
Z-2496-2023 · Jul 27, 2023 · Open, Classified
Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.

…and 2 more.

Device details

UDI-DI	`04953170298622`
Brand	EVIS EXERA III VIDEO SYSTEM CENTER
Model	OLYMPUS CV-190
Company	Olympus Medical Systems Corp.
Product code	NWB · Endoscope, accessories, narrow band spectrum
Class	Class 2
FDA submission	K121959, K123365, K131780
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 22, 2024

Device type (GMDN): Endoscopic video image processing unit

An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Other Endoscope, accessories, narrow band spectrum devices

HD CAMERA HEAD OLYMPUS CH-S190-08-LB
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3,793 reports
EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190L
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2 recalls2,828 reports
EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180V
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6 deaths2,362 reports
VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190
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1,563 reports
HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-E
Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum
1,424 reports
VIDEO SYSTEM CENTER Type A OLYMPUS CV-170
Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum
841 reports
EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180V
Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum
1 recall3 deaths653 reports
SINGLE USE DISTAL COVER MAJ-2315
Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum
1 recall520 reports

All Endoscope, accessories, narrow band spectrum devices →

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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page