iLED 4028210Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00887761995956), received between Jul 10, 2020 and Apr 29, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Flaked” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ILED 3 SURGICAL LIGHT FELL DOWN AS THE SPRING ARM SEPARATED FROM THE SUPPORT ARM SYSTEM. THE FALLING COMPONENT HIT A PERSON AT THE SHOULDER AND THE KNEE. THE PERSON IS CURRENTLY ON SICK LEAVE. NO DETAILS OF THE INJURY , RESULTS OF X-RAY AND MEDICAL EXAMINATION WERE NOT PROVIDED BY THE CUSTOMER SO FAR. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14249897 ↗
• MalfunctionOct 1, 2021Flaked; Flaked

  CUSTOMER REPORTED THAT THE PAINT IS FALLING DOWN FROM THE SURGICAL LIGHT. THE DEVICE WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565855 ↗
• MalfunctionOct 1, 2021Flaked; Flaked

  THE CUSTOMER ALLEGED THAT PAINT IS FALLING DOWN FROM THE SURGICAL LIGHT. NO INJURY OR IMPACT TO ANY SURGICAL PROCEDURE 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 12565748 ↗
• MalfunctionOct 1, 2021Flaked; Flaked

  THE CUSTOMER ALLEGED THAT PAINT IS FALLING DOWN FROM THE SURGICAL LIGHT. NO INJURY OR IMPACT TO ANY SURGICAL PROCEDURE 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 12565714 ↗
• MalfunctionOct 1, 2021Flaked; Flaked

  CUSTOMER REPORTED THAT THE PAINT IS FALLING DOWN FROM THE SURGICAL LIGHT. THE DEVICE WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565445 ↗
• MalfunctionOct 1, 2021Flaked; Flaked

  CUSTOMER REPORTED THAT THE PAINT IS FALLING DOWN FROM THE SURGICAL LIGHT. THE DEVICE WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565423 ↗
• MalfunctionMar 12, 2021Structural Problem; Detachment of Device or Device Component; Structural Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE SPRING ARM WITH LIGHT HEAD SEPARATED FROM THE CENTRAL AXIS. IT DID NOT FALL DOWN. NO INJURY OR IMPACT TO A SURGICAL PROCEDURE REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11471803 ↗
• MalfunctionNov 24, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT A LIGHT HEAD DROPPED DOWN AND HIT A USER AT THE HEAD. ACCORDING TO INITIAL INFORMATION, THE USER RECEIVED A LACERATION ON THE HEAD AND A MILD CONCUSSION. WITH THE CURRENT INFORMATION PROVIDED BY THE CUSTOMER, THE INJURY IS NOT CONSIDERED AS AN UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Concussion; Laceration(s)

  MAUDE report 10894953 ↗
• MalfunctionJul 10, 2020Degraded; Flaked; Material Integrity Problem; Degraded; Flaked; Material Integrity Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 10256959 ↗
• MalfunctionJul 10, 2020Degraded; Flaked; Material Integrity Problem; Degraded; Flaked; Material Integrity Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 10256953 ↗