HALOGEN LIGHT SOURCE CLH-SC (REF 5720442)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04953170024467), received between Oct 30, 2020 and Jun 11, 2026 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (11 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 25 most recent of 42 reports, 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 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 ↗
• MalfunctionFeb 20, 2026No Device Output

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402474 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BROKEN POWER SWITCH AT THE POINT WHERE THE POWER CORD PLUGGED INTO THE MACHINE. THE PLASTIC THAT HELD IT IN PLACE WAS DAMAGED, PREVENTING IT FROM STAYING SECURE, AND THE BRACKET WAS ALSO BROKEN. THE ISSUE WAS IDENTIFIED DURING SET UP/INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141539 ↗
• MalfunctionMar 15, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED, THE LIGHT SOURCE¿S LAMP WAS FUSED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913266 ↗
• MalfunctionMar 13, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE EXHIBITED THE CERAMIC LAMP SOCKET UNIT WAS LOOSE WHEN CONNECTED TO HALOGEN LAMP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895369 ↗
• MalfunctionMar 12, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THAT THE LAMP OF THE LIGHT SOURCE WOULD NOT LIGHT. THE CUSTOMER EXCHANGED THE BULB WITH NO CHANGE. THE ISSUE WAS FOUND DURING ROUTINE MAINTENANCE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886028 ↗
• MalfunctionFeb 2, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT THE HALOGEN LIGHT SOURCE HAD STOPPED WORKING, DID NOT PROVIDE LIGHT AND THEY TRIED A NEW LIGHT BULB WITHOUT SUCCESS. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631666 ↗
• MalfunctionDec 26, 2023No Device Output; No Device Output

  THE CUSTOMER REPORTED TO OLYMPUS, THE LIGHT SOURCE LAMP DID NOT WORK. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392232 ↗
• MalfunctionNov 17, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE HALOGEN LIGHT SOURCE LAMP DID NOT LIGHT UP. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159480 ↗
• MalfunctionAug 29, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE POWER DOES NOT TURN ON. UPON INSPECTION AND EVALUATION, THE DEVICE DOES NOT TURN. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING INCOMING INSPECTION AND EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17645278 ↗
• MalfunctionAug 28, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE DID NOT LIGHT WHEN POWERED ON. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A DIAGNOSTIC INTRAUTERINE EXAMINATION, WHICH WAS CANCELLED AS A RESULT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638188 ↗
• MalfunctionAug 12, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HALOGEN LIGHT SOURCE DOES NOT TURN ON, (NO LIGHT), AND THERE WAS A DISCONNECTION ISSUE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17537790 ↗
• MalfunctionJun 7, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED THAT WHILE PERFORMING MAINTENANCE ON HER OLYMPUS HALOGEN LIGHT SOURCE, THE LAMP WAS NOT LIGHTING. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078972 ↗
• MalfunctionApr 27, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO OLYMPUS, THAT THE HALOGEN LIGHT SOURCE LAMP DID NOT LIGHT. THE ISSUE WAS FOUND DURING INSPECTION FOR USE FOR A DIAGNOSTIC PROCEDURE AND IT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825037 ↗
• MalfunctionApr 20, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO THE DISTRIBUTOR, THAT THE HALOGEN LIGHT SOURCE WAS NOT TURNING ON. THE ISSUE WAS FOUND DURING INSPECTION FOR USE FOR A DIAGNOSTIC PROCEDURE AND IT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781989 ↗
• MalfunctionMar 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THEIR HALOGEN LIGHT SOURCE HAD A LAMP WHICH DID NOT LIGHT, AND ASKED IF PREVENTATIVE MAINTENANCE WAS REQUIRED. FOLLOWING A CALL WITH AN OLYMPUS REPRESENTATIVE, THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE AFTER CHANGING THE UNIT¿S BULB, AND AN OLYMPUS REPRESENTATIVE PROVIDED A MAINTENANCE AND INSTRUCTION MANUAL TO THE CUSTOMER. THE CUSTOMER DECLINED TO RETURN THE DEVICE FOR EVALUATION. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534291 ↗
• MalfunctionFeb 21, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED TO OLYMPUS THE HALOGEN LIGHT SOURCE COULD NOT TURN ON. THE ISSUE WAS FOUND DURING RECEIPT INSPECTION OF THE DEVICE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE POOR LAMP LIGHTING AND LAMP HARNESS FAILURE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409425 ↗
• MalfunctionJan 24, 2023Output Problem; Output Problem

  ON DECEMBER 20, 2022, THE CUSTOMER¿S REPORTED ISSUE WAS FOUND DURING INSPECTION BEFORE USE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231205 ↗
• MalfunctionJan 22, 2023Optical Problem; Optical Problem

  THE CUSTOMER REPORTED THE HALOGEN LIGHT SOURCE FAILS TO LIGHT. THE EVENT OCCURRED DURING A DIAGNOSTIC PROCEDURE AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221767 ↗
• MalfunctionJan 12, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE CONNECTOR WAS DAMAGED AND CANNOT BE CONNECTED ON THE HALOGEN LIGHT SOURCE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148106 ↗
• MalfunctionNov 23, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONFIRMED THE DEVICE WAS INSPECTED BEFORE USE. THE EVENT OCCURRED DURING AN UNKNOWN DIAGNOSTIC AND THERAPEUTIC PROCEDURE. AFTER CHECKING THE CONNECTION PART OF THE LAMP, IT LIT UP, SO THERE WAS NO EFFECT ON THE TREATMENT. THERE WAS A TEN (10) MINUTE DELAY REPORTED. THE PROCEDURE WAS COMPLETED WITHOUT THE NEED TO CHANGE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853765 ↗
• MalfunctionNov 16, 2022Electrical Power Problem; Electrical Power Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN THE HALOGEN LIGHT SOURCE WAS TURNED ON, AN ABNORMAL NOISE OCCURRED, AND THE LAMP DID NOT LIGHT. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE (COLPOSCOPE), AND THE PROCEDURE WAS POSTPONED BECAUSE OF THE ISSUE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808969 ↗
• MalfunctionSep 15, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS FURTHER REPORTED THAT THE PROBLEM WAS FIRST IDENTIFIED DURING PREPARATION FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15433659 ↗
• MalfunctionAug 2, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED THAT HIS OLYMPUS HALOGEN LIGHT SOURCE¿S LAMP WAS NOT TURNING ON DURING USE. 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 15146408 ↗