XENON LAMP MAJ-1817Recalls & reported problems
Olympus Medical Systems Corp. · MAJ-1817 CLV-190 REPLACEMENT BULB. · Class 2
All models of Xenon Lamp (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus MAJ-1817 xenon lamp is a replacement bulb unit for a video processor used with colonoscopes. The 61 reports mostly describe the lamp and its processor failing to light properly — dim or dark images, blurry pictures, a noisy screen, startup error codes, and no picture output at all — with problems often spotted during routine inspection or maintenance. There are no deaths and no injuries. 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
- 61
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 04953170304835), received between Oct 19, 2020 and May 25, 2026 — classified as 61 malfunctions.
The most frequently reported specific device problem is “Output Problem” (9 reports).
8 other recalls cover devices cleared under the same FDA submission (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
Most reported problems
Device problems
- Output Problem9
- Communication or Transmission Problem8
- No Device Output8
- Optical Problem8
- No Visual Prompts/Feedback5
- Poor Quality Image5
- Electrical /Electronic Property Problem4
- Temperature Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2026Optical Problem
IT WAS REPORTED THAT THE LAMP EXHIBITED INSUFFICIENT BRIGHTNESS. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25271003 ↗MalfunctionApr 29, 2026Poor Quality Image; Output Problem; Activation Failure
IT WAS REPORTED THAT THE LAMP DISPLAYED A BLURRY AND DARK IMAGE, AND THE BULB DID NOT LIGHT. THE EVENT OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035349 ↗MalfunctionJan 2, 2026Poor Quality Image; Output Problem
IT WAS REPORTED THAT THE XENON LAMP EXPERIENCED A NOISED SCREEN AND A BULB ERROR. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23945065 ↗MalfunctionJan 2, 2026Poor Quality Image
IT WAS REPORTED THAT THE XENON LAMP HAD A NOISY SCREEN. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944950 ↗MalfunctionDec 29, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23910826 ↗MalfunctionDec 23, 2025Poor Quality Image; Poor Quality Image
THE REPORTED DARK IMAGE HAPPENED DURING UNSPECIFIED DIAGNOSTIC PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878842 ↗MalfunctionNov 11, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE LAMP EXHIBITED INSUFFICIENT BRIGHTNESS AFTER ABOUT A WEEK OF USE AND OCCASIONALLY FAILED TO LIGHT UP NORMALLY, RESULTING IN A STARTUP ERROR (E102). THE ISSUE WAS IDENTIFIED DURING INSPECTION FOR USE BEFORE SEDATION OF A DIAGNOSTIC GENERAL MEDICAL TREATMENT PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526769 ↗MalfunctionNov 11, 2025Output Problem; Output Problem
IT WAS REPORTED THE LAMP EXHIBITED AN ERROR AND THE BRIGHTNESS WAS INSUFFICIENT; IT WAS UNABLE TO LIGHT UP OCCASIONALLY. THE ISSUE WAS FOUND DURING SEDATION FOR A DIAGNOSTIC GENERAL EXAMINATION PROCEDURE AND WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526713 ↗MalfunctionNov 11, 2025No Device Output; No Device Output
IT WAS REPORTED THAT THE LAMP HAD AN ERROR, THE BRIGHTNESS WAS INSUFFICIENT. THE ISSUE WAS FOUND DURING A DIAGNOSTIC GENERAL EXAMINATION PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526642 ↗MalfunctionNov 11, 2025No Device Output; Output Problem; No Device Output; Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525902 ↗MalfunctionNov 11, 2025Display or Visual Feedback Problem; Activation Failure; Display or Visual Feedback Problem; Activation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525838 ↗MalfunctionSep 15, 2025Output below Specifications; Temperature Problem; Output below Specifications; Temperature Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23053566 ↗MalfunctionApr 18, 2025Activation Problem; Activation Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21867815 ↗MalfunctionMar 27, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE MECHANICAL ACC: MAJ-1817 EXHIBITED AN ERROR 102. THIS ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708724 ↗MalfunctionOct 22, 2024No Device Output; Communication or Transmission Problem; No Device Output; Communication or Transmission Problem
IT WAS REPORTED THAT DURING A PREPARATION FOR USE, THE XENON LAMP FAILED TO LIGHT AFTER SEVERAL CLICKS AND DISPLAYED AN ERROR E103, THE DEVICE WAS USED LESS THAN 100 HOURS. THE PATIENT WAS NOT UNDER ANESTHESIA AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20506424 ↗MalfunctionSep 24, 2024Unintended Power Up; Noise, Audible; Unintended Power Up; Noise, Audible
IT WAS REPORTED THAT THE SUBJECT DEVICE LIGHT TURNED ON AND OFF CONTINUOUSLY WITH A CRACKLING SOUND. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC UPPER GASTROINTESTINAL ENDOSCOPY PROCEDURE. AFTER RESTARTING THE MACHINE SEVERAL TIMES, THE TEST WAS PERFORMED NORMALLY. THE START OF THE TEST WAS DELAYED BY ABOUT 10 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20294252 ↗MalfunctionJun 11, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THE LIGHT SOURCE WAS SWITCHING TO THE SPARE LAMP EVERY TIME THEY PLUGGED IN A NEW SCOPE. THE ISSUE WAS FOUND BEFORE THE START OF A THERAPEUTIC PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND A DELAY WAS REPORTED, BUT THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19515579 ↗MalfunctionJun 6, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE LIGHT SOURCE EXHIBITED A FAULTY SCOPE SOCKET / SCOPE COMMUNICATION ERROR (B30). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480688 ↗MalfunctionMay 8, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THAT THE LIGHT SOURCE WAS DIM. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19269213 ↗MalfunctionMay 7, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE LIGHT SOURCE HAD CONNECTOR ISSUES. IT WORKS WITH SOME SCOPES, BUT NOT ALL. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19262250 ↗MalfunctionApr 25, 2024Defective Component; Defective Component
IT WAS REPORTED THAT THE LIGHT IN THE XENON LAMP WENT OUT AFTER 100 HOURS WHILE BEING USED ON THE ENDO TOWER. THE ISSUE OCCURRED AFTER A DIAGNOSTIC GASTROINTESTINAL PROCEDURE. THE DEVICE WAS EXCHANGED AND THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181862 ↗MalfunctionApr 24, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE LIGHT SOURCE WAS NOT WORKING ON THE 180 SCOPES AND NOT RECOGNIZING THE 190 SCOPES. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175363 ↗MalfunctionApr 11, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THE XENON LIGHT SOURCE HAD THE MONITOR FLASHES BETWEEN COLOR BARS AND SCOPE IMAGE. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19093798 ↗MalfunctionApr 9, 2024Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE LIGHT SOURCE POWER SWITCH CANNOT BE TURNED ON. THE ISSUE OCCURRED DURING AN UNKNOWN DIAGNOSTIC EVENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19076646 ↗MalfunctionMar 12, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback
IT WAS REPORTED THAT THE XENON LAMP FAILS TO IGNITE. THE ISSUE OCCURRED DURING A THERAPEUTIC GASTROENDOSCOPY. THERE WAS AN UNSPECIFIED DELAY; HOWEVER, THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18887998 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131780. One submission often covers many models, so check the product and lot details in each record.
- Z-1210-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-H190DL.
- Z-0419-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0417-2024 · Oct 16, 2023 · Open, ClassifiedGIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0416-2024 · Oct 16, 2023 · Open, ClassifiedGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0415-2024 · Oct 16, 2023 · Open, ClassifiedCF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Z-0418-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0341-2024 · Sep 25, 2023 · Open, ClassifiedColonoscope-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-0056-2025 · Sep 14, 2023 · Open, ClassifiedEVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancil
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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