HALOGEN LIGHT SOURCERecalls & reported problems across all models
Olympus Medical Systems Corp. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 276
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 7 models of HALOGEN LIGHT SOURCE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 276 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2019 and Jun 11, 2026 — classified as 1 injury, 275 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (59 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported HALOGEN LIGHT SOURCE problems
Device problems
- Failure to Power Up59
- Electrical /Electronic Property Problem39
- No Visual Prompts/Feedback29
- No Device Output24
- Break23
- Optical Problem15
- Power Problem14
- Output Problem13
Patient problems
- No Clinical Signs, Symptoms or Conditions241
- No Consequences Or Impact To Patient25
- No Patient Involvement10
- Insufficient Information1
- Laceration(s)1
- No Information1
HALOGEN LIGHT SOURCE models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HALOGEN LIGHT SOURCE OLYMPUS CLK-4FORCEPS, BIOPSY, ELECTRIC65 reports
- HALOGEN LIGHT SOURCE OLYMPUS CLK-4Kit, nephroscope61 reports
- HALOGEN LIGHT SOURCE CLH-250BRONCHOSCOPE (FLEXIBLE OR RIGID)47 reports
- HALOGEN LIGHT SOURCE CLH-SCGastroscope And Accessories, Flexible/Rigid42 reports
- HALOGEN LIGHT SOURCE CLH-SCKit, nephroscope37 reports
- HALOGEN LIGHT SOURCE CLH-SCGastroscope And Accessories, Flexible/Rigid13 reports
- HALOGEN LIGHT SOURCE CLH-250BRONCHOSCOPE (FLEXIBLE OR RIGID)11 reports
Recent HALOGEN LIGHT SOURCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Activation Problem
THE CUSTOMER RETURNED THE HALOGEN LIGHT SOURCE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD BLOWN OUT SPARE LAMP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476557 ↗MalfunctionMay 25, 2026Overheating of Device
THE CUSTOMER RETURNED THE HALOGEN LIGHT SOURCE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, BURNT-OUT BULB WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN ASSESSED THE CONDITION AND DETERMINED THAT THE DAMAGE WAS MOST LIKELY DUE TO HIGH-ENERGY INSTRUMENTS (SUCH AS HIGH-FREQUENCY DEVICES) WERE USED WITHOUT MAINTAINING SUFFICIENT DISTANCE FROM THE TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25271688 ↗MalfunctionMay 11, 2026Poor Quality Image
IT WAS REPORTED THAT THE HALOGEN LIGHT SOURCE EXHIBITED DIM ILLUMINATION IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25138341 ↗MalfunctionMay 7, 2026Naturally Worn
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE HALOGEN LIGHT SOURCE FAILED TO ILLUMINATE, WHICH WAS ATTRIBUTED TO A WORN LAMP SOCKET. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116682 ↗MalfunctionApr 30, 2026Activation Failure
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE LAMP WAS NOT GETTING ON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039160 ↗MalfunctionApr 23, 2026Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE EXHIBITED LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965616 ↗MalfunctionMar 9, 2026Activation Failure
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE HAD FAILURE TO START UP DUE TO THE TEMPERATURE SENSOR MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543535 ↗MalfunctionMar 9, 2026Output Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE PRESENTED AN ISSUE IN WHICH THE BULBS FREQUENTLY BURNED OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543330 ↗MalfunctionFeb 26, 2026Optical Problem
IT WAS REPORTED THAT THE HALOGEN LIGHT SOURCE EXHIBITED A MALFUNCTION IN WHICH THE LIGHT SOURCE WAS BURNING OUT THE BULBS. THE ISSUE WAS DETECTED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461541 ↗MalfunctionFeb 26, 2026Activation Failure
IT WAS REPORTED THAT THE HALOGEN LIGHT SOURCE BULB WAS FREQUENTLY BURNED OUT. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456622 ↗MalfunctionFeb 25, 2026Overheating of Device
IT WAS REPORTED THE BULB OF LIGHT SOURCE FREQUENTLY BURNED OUT. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24449463 ↗MalfunctionFeb 20, 2026No Device Output
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402474 ↗MalfunctionFeb 17, 2026Activation Problem
IT WAS REPORTED THE HALOGEN LIGHT SOURCE WAS NOT WORKING DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363047 ↗MalfunctionJan 16, 2026Failure to Power Up
IT WAS REPORTED HALOGEN LIGHT SOURCE WAS NOT POWERED ON DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092933 ↗MalfunctionJan 2, 2026No Device Output
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943057 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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