iLED 4028310Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887761995949), received between Oct 14, 2020 and Sep 9, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Flaked” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE CLEANING OF THE SURGICAL ROOM THE LIGHT HEAD ILED DETACHED FROM THE SPRING ARM AND FELL OFF. THE CRESENT KEY CAME OUT (THIS ALLOWED THE LIGHT HEAD TO DETACH). THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15390813 ↗
• MalfunctionJun 29, 2022Break; Defective Component; Break; Defective Component

  IT WAS ALLEGED BY THE CUSTOMER THAT AT THE START OF THE DAY IT WAS NOTICED THE ILED LIGHTING SYSTEM AT THE CEILING WAS TILTED AND NO LONGER STABLE. NO HARM OR IMPACT TO A SURGICAL PROCEDURE WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852772 ↗
• MalfunctionDec 22, 2021Flaked; Flaked

  IT WAS REPORTED WHEN THE SURGEON POSITIONED TWO ILED LIGHT HEADS OVER THE STERILE SURGICAL FIELD, THE TWO LIGHT HEADS COLLIDED. AS A RESULT PAINT PARTICLES FELL OFF OF THE DEVICE AND ON THE PATIENT¿S OPEN ABDOMEN. NO INJURY WAS REPORTED BUT A DERMAL APPLICATION OF A BETADINE ANTISEPTIC SOLUTION WAS PROVIDED TO THE AREA OF SURGERY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060574 ↗
• MalfunctionAug 31, 2021Flaked; Flaked

  THE CUSTOMER ALLEGED THE PAINT IS CHIPPING FROM THE SURGICAL LIGHT EVERY DAY DURING USE. NO INJURIES WERE REPORTED IN RELATION TO THIS ALLEGATION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12390964 ↗
• MalfunctionMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE STERILE HANDLE DETACHED DURING A SURGICAL PROCEDURE FROM THE LIGHT HEAD AND LANDED ON THE PATIENTS LEGS. NO INJURY WAS REPORTED IN RELATION TO THIS ALLEGATION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782629 ↗
• MalfunctionMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE LOCKING MECHANISM FOR THE STERILE HANDLE IS BROKEN. DURING DEVICE INSPECTION BY A FIELD SERVICE TECHNICIAN THE CUSTOMER REPORTED THAT THE STERILE HANDLE DID FELL OFF SEVERAL TIMES IN THE PAST, ONE TIME IT FELL ONTO THE HAND OF AN OR STAFF MEMBER. NO INJURY WAS REPORTED IN RELATION TO THIS ALLEGATION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782626 ↗
• MalfunctionFeb 25, 2021Degraded; Flaked; Material Integrity Problem; Degraded; Flaked; Material Integrity Problem

  THE CUSTOMER ALLEGED THAT DURING THE DAILY USE OF THE DEVICE PAINT PARTICLES ARE CHIPPING FROM THE LIGHT HEAD. NO INJURIES WERE REPORTED IN RELATION TO THIS ALLEGATION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11378017 ↗
• MalfunctionFeb 25, 2021Degraded; Flaked; Material Integrity Problem; Degraded; Flaked; Material Integrity Problem

  THE CUSTOMER ALLEGED THAT DURING THE DAILY USE OF THE DEVICE PAINT PARTICLES ARE CHIPPING FROM THE LIGHT HEAD. NO INJURIES WERE REPORTED IN RELATION TO THIS ALLEGATION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11378009 ↗
• MalfunctionOct 14, 2020Degraded; Flaked; Material Integrity Problem; Degraded; Flaked; Material Integrity Problem

  THE CUSTOMER ALLEGED PAINT IS CHIPPING FROM THE LIGHT HEAD. NO INJURIES REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #: (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10677770 ↗