EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus EVIS X1 video system is the imaging unit used with colonoscopes, and its 503 reports mostly describe no image on screen, with some describing flickering. There are no deaths and 18 injuries reported, with patient problems listed including a collapsed lung and bowel perforation. Reports rose to 167 in the past year from 101 in the year before. No recalls name this device.
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
- 514
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 514 adverse event reports that list this exact device (DI 04953170414596), received between Jun 21, 2023 and Sep 30, 2026 — classified as 18 injuries, 496 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (377 reports).
1 other recall cover devices cleared under the same FDA submission (K222584, K222861); 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
Most reported problems
Device problems
- No Display/Image377
- Poor Quality Image41
- Erratic or Intermittent Display27
- Communication or Transmission Problem19
- Output Problem14
- Corroded12
- Free or Unrestricted Flow6
- Image Display Error/Artifact4
Patient problems
- No Clinical Signs, Symptoms or Conditions508
- Pneumothorax5
- Bowel Perforation2
- Laceration(s)2
- Pneumoperitoneum2
- Respiratory Failure2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 514 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Self-Activation or Keying
The customer reported that the air supply automatically turned on when a scope was connected 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 50941828 ↗MalfunctionSep 28, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915532 ↗MalfunctionSep 25, 2026Erratic or Intermittent Display
The customer reported glitching during set-up and 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 50902988 ↗MalfunctionSep 25, 2026No Display/Image
The customer reported that device was unable to capture image when the Olympus endoscope remote switch 4 is pressed during diagnostic colonoscopy procedure involving an Olympus video system center. The procedure was completed with the same device. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897187 ↗MalfunctionSep 23, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873452 ↗MalfunctionSep 23, 2026Erratic or Intermittent Display
The customer reported the screen started flashing during inspection for use involving an Olympus video system center. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872354 ↗MalfunctionSep 21, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847304 ↗MalfunctionSep 21, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845845 ↗MalfunctionSep 17, 2026Erratic or Intermittent Display
The customer reported screen is flashing and blinking during an Inspection for use involving an Olympus video system center. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801241 ↗MalfunctionSep 10, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718474 ↗MalfunctionSep 4, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50613476 ↗MalfunctionSep 2, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569153 ↗MalfunctionAug 31, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50529488 ↗MalfunctionAug 31, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50521980 ↗MalfunctionAug 27, 2026No Display/Image
The customer reported images could not be captured during inspection for use involving an Olympus video system center. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50484917 ↗MalfunctionAug 27, 2026Display or Visual Feedback Problem
The customer reported that the secondary screen was flickering and intermittently going black during image capture in a multiple diagnostic procedure involving the Olympus Video System Center. During sedation, the device was inside the patient, and a backup Olympus device was used. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478738 ↗MalfunctionAug 26, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458222 ↗MalfunctionAug 26, 2026Poor Quality Image
The customer reported lamp flickers 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 50456073 ↗MalfunctionAug 26, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452800 ↗MalfunctionAug 26, 2026No Display/Image
The customer reported no signal on serial digital interface (SDI) during inspection prior to use involving an Olympus video system center. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450344 ↗MalfunctionAug 26, 2026No Display/Image
The customer reported screen goes black during a colonoscopy diagnostic procedure involving an Olympus video system center. The procedure was completed with the same device. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50443839 ↗MalfunctionAug 14, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50257726 ↗MalfunctionAug 12, 2026Poor Quality Image
The customer returned the Video System Center to the service center for a separate issue. During the device analysis, the service repair technician indicated that flickering and lines in the image were found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50226086 ↗MalfunctionAug 12, 2026No Display/Image
The customer reported that the endoscopic image blacked out during a diagnostic colonoscopy procedure while the patient was under sedation and the device was inside the patient involving an Olympus Video System Center. The customer contacted Olympus Technical Assistance Center (TAC) by phone and reported a problem with the image. No troubleshooting was performed, as the customer indicated that TAC support was contacted in error and requested repair processing only. The device will be returned to Olympus for evaluation. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221383 ↗MalfunctionAug 7, 2026No Display/Image
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177391 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K222584, K222861. One submission often covers many models, so check the product and lot details in each record.
- Z-0181-2025 · Aug 21, 2024 · Open, ClassifiedOlympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Other Colonoscope And Accessories, Flexible/Rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 reports
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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