Halogen Lamp MD-151Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04953170064319), received between Jan 14, 2021 and Oct 29, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THE HALOGEN LAMP DID NOT LIGHT UP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414105 ↗
• MalfunctionJul 3, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE SUBJECT DEVICE BURNED OUT ON THE THIRD USE. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE, WHICH WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22397356 ↗
• MalfunctionApr 24, 2025Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902250 ↗
• MalfunctionAug 27, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THE HALOGEN LAMP DID NOT LIGHT UP. THE ISSUE OCCURRED DURING PREPARATION FOR USE OF DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080994 ↗
• MalfunctionApr 24, 2024No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THAT DURING THE PRE-USE INSPECTION, AN ERROR OCCURRED ON THE VIDEO SYSTEM LAMP. THE INTENDED PROCEDURE WAS COMPLETED USING A REPLACEMENT LAMP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176432 ↗
• MalfunctionAug 7, 2023No Device Output; No Device Output

  THE CUSTOMER REPORTED TO OLYMPUS, THE HALOGEN LAMP A AND B HAD ERRORS ON THE OTV-SI LIGHT SOURCE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476593 ↗
• MalfunctionNov 4, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED "THE FACILITY STAFF ATTACHED THE HALOGEN LAMP (MD-151) TO THE DEVICE (OTV-SI) AND LAMP DID NOT TURN ON. THE ISSUE OCCURRED AT PREPARATION FOR USE. ACCORDING TO THE REPORT, THE DEVICE WAS REPLACED AS THE ACTION TAKEN AT THE CUSTOMER SITE . THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726739 ↗
• MalfunctionSep 6, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER WHICH NOTED THE REPORTED EVENT (B30 ERROR) OCCURRED PRIOR TO AN OBSERVATION PROCEDURE. THE PROCEDURE WAS ¿COMPLETED AS IS¿ AND THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15364073 ↗
• MalfunctionAug 10, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED, THE HALOGEN LAMP ( MD-151 ) DID NOT LIGHT WHEN THE FACILITY STAFF REPLACED IT AS IT WAS OUT ON THE CLH-SC (HALOGEN LIGHT SOURCE). ANOTHER NEW MD-151 WAS USED AND WAS NOTED THAT IT WORKED WITHOUT ANY ISSUES AND HAD NO EFFECT ON THE CASE. THE ISSUE OCCURRED AT PREPARATION FOR USE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198207 ↗
• MalfunctionDec 14, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE UNSPECIFIED TIMING, A LAMP ERROR OCCURRED ON THE OTV-SI. THE OTV-SI WAS RETURNED TO OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC). SORC CHECKED THE OTV-SI AND THERE WAS NO ABNORMALITY OF THE OTV-SI. SORC FOUND THAT THE LAMP B (MD-151) OF THE OTV-SI WAS BROKEN. LAMP B DID NOT LIT. THE EVENT DATE WAS UNKNOWN. 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 12998972 ↗
• MalfunctionOct 11, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE UNSPECIFIED TIMING, THE HALOGEN LAMP OF THE OTV-SI WAS REPLACED WITH THE SUBJECT DEVICE, BUT THE SUBJECT DEVICE WAS NOT LIT UP. THE USER REPLACED THE SUBJECT DEVICE WITH ANOTHER MD-151, AND THE OTHER MD-151 WAS LIT UP. THERE WAS NO ABNORMALITY OF THE APPEARANCE OF THE SUBJECT DEVICE. 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 12604408 ↗
• MalfunctionAug 26, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE INSPECTION BEFORE USE, IT WAS FOUND THAT THE SUBJECT DEVICE (HALOGEN LAMP) WHICH WAS INSTALLED INTO THE VIDEO SYSTEM CENTER OTV-SI DID NOT LIGHT UP. THE USER FACILITY SWITCHED THE SUBJECT DEVICE TO OTHER LAMP WHICH WAS INSTALLED INSIDE THE OTV-SI AND COMPLETED THE INTENDED PROCEDURE WITH SAME OTV-SI WITHOUT ANY PROBLEMS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370314 ↗
• MalfunctionAug 9, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY ONE OF THE HEALTH PROFESSIONALS AT THE USER FACILITY THAT DURING THE PREPARATION OF A OTORHINOLARYNGOLOGY ENDOSCOPY USING THE SUBJECT DEVICE AND OTV-SI, THE LAMP DID NOT LIGHT UP. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298710 ↗
• MalfunctionFeb 15, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING PREPARATION FOR USE, IT WAS FOUND THAT THE SUBJECT DEVICE COULD NOT LIGHT UP WITHIN LESS THAN A MONTH. THE USER FACILITY EXCHANGED TO THE SPARE LAMP AND COMPLETED THE INTENDED PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11326867 ↗
• MalfunctionJan 17, 2021Break; Break

  DURING PREPARATION FOR USING THE OTV-SI, THE DEVICE (HALOGEN LAMP MD-151) OF THE OTV-SI WENT OFF AFTER BEING USED FOR 2-3 DAYS. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11183402 ↗
• MalfunctionJan 14, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE UNSPECIFIED TIMING, THE LAMP ERROR OCCURRED. THE USER CHANGED ANOTHER LAMP AND ITS ERROR WAS SOLVED. OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. ON DECEMBER 22, 2020, (OMSC) COMPLETED TO EVALUATE THE RISK OF THE REPORTED PHENOMENON AND DECIDED THAT THE PHENOMENON WAS PAE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11168883 ↗
• MalfunctionJan 14, 2021Break; Break

  DURING PREPARATION FOR USING THE CLH-SC AND THE COLPOSCOPE, THE DEVICE (HALOGEN LAMP MD-151) OF THE CLH-SC WENT OFF. THE USER REPLACED THE CLH-SC TO ANOTHER DEVICE COMPLETE THE PROCEDURE. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11168614 ↗