HALOGEN LIGHT SOURCE CLH-SC (REF 5720461)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170024474), received between May 20, 2021 and Feb 26, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “No Visual Prompts/Feedback” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 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 2, 2026No Device Output

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943057 ↗
• MalfunctionAug 14, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THAT THE LIGHTSOURCE LIGHT COULD NOT TURN. THE ISSUE WAS FOUND DURING A SETTING UP OF THE DEVICE BEFORE THE PATIENT ENTERED THE ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803537 ↗
• MalfunctionJun 24, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LIGHTSOURCE EXHIBITED ABNORMALITY WITH THE HALOGEN LAMP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320694 ↗
• MalfunctionMay 30, 2025Break; Optical Obstruction; Break; Optical Obstruction

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED LAMP DID NOT LIGHT UP AND THERMAL FUSE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117994 ↗
• MalfunctionMay 14, 2025No Visual Prompts/Feedback; Activation Problem; No Visual Prompts/Feedback; Activation Problem

  IT WAS REPORTED THAT THE HALOGEN LIGHT SOURCE WAS UNABLE TO LIGHT THE LAMP. THE ISSUE WAS FOUND DURING SERVICE / MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017370 ↗
• MalfunctionJun 3, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT THERE WAS NO LIGHT FROM THE HALOGEN LIGHT SOURCE, THE LAMP WAS CHANGED, BUT THERE WAS STILL NO LIGHT. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448387 ↗
• MalfunctionMar 15, 2024No Device Output; No Device Output

  IT WAS REPORTED, THE HALOGEN LIGHT SOURCE HAD THE LAMP KEPT BLOWING ON THIS UNIT. TWO LAMP FAILED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915211 ↗
• MalfunctionOct 27, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED TO OLYMPUS, THE HALOGEN LIGHT SOURCE DID NOT LIGHT UP AFTER REPLACEMENT. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021772 ↗
• MalfunctionAug 3, 2023Electrical Power Problem; Electrical Power Problem

  THE CUSTOMER REPORTED THAT HIS OLYMPUS HALOGEN LIGHT SOURCE WAS EXPERIENCING LAMP LIGHTING ISSUES. ACCORDING TO THE INITIAL REPORTER, EVERY TIME HE PUT IN A NEW BULB, IT WOULD BLOW OUT. REPORTEDLY, THE UNIT IS PUTTING OUT 16 VOLTS WHEN IT SHOULD ONLY BE PUTTING OUT 12 VOLTS. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450058 ↗
• MalfunctionMay 20, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE UNSPECIFIED TIMING, THE LAMP HOLDER WAS DAMAGED. THE USER REPLACED THE DEVICE WITH ANOTHER SYSTEM TO COMPLETE THE PROCEDURE. THE SUBJECT DEVICE WAS RETURNED TO THE OLYMPUS LOCAL SERVICE DEPARTMENT. THE OLYMPUS LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND FOUND THAT THE EXAMINATION LAMP OF THE SUBJECT DEVICE DID NOT LIGHT UP DUE TO THE BREAKAGE OF THE LAMP SOCKET. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853541 ↗