iLED 4068310Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887761995840), received between Sep 29, 2022 and Mar 30, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Detachment of Device or Device Component

  BAXTER RECEIVED A REPORT THAT ILED7 TRIO/QUAD HAD SPRING ARM FALLING OFF THE CENTER AXIS. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736185 ↗
• MalfunctionFeb 28, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE CUSTOMER ALLEGED THAT DURING A SURGICAL PROCEDURE, THE ILED SURGICAL LIGHT SYSTEM BURNED A PATIENT. FOLLOW-UP WITH THE CUSTOMER FOUND THAT THE BURN WAS REPORTED TO BE A FULL THICKNESS BURN AND ¿WOULD REQUIRE ADDITIONAL SURGERY TO MANAGE THE BURN. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 21490523 ↗
• MalfunctionApr 5, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT WHEN THE FACILITY MANAGER EXPERIMENTED THE ILED 7 CEILING TRIO LIGHTS ON HIMSELF HE FELT WARM UNDER THE OT SCRUB AND OBSERVED REDNESS AFTER 20 MINS. IT WAS NOTED THAT THE 3 LIGHTS WERE BEING USED AT THE SAME TIME, AND SET AT 100% INTENSITY AND 5000K COLOUR TEMPERATURE. NO MEDICAL INTERVENTION WAS REQUIRED. DURING FOLLOW-UP WITH THE CUSTOMER, IT WAS NOTED THAT THE CUSTOMER WAS UNAWARE OF THE REMAINING RISK ASSOCIATED WITH THE OVERLAPPING OF 2 OR MORE LIGHTS. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051040 ↗
• MalfunctionApr 5, 2024Insufficient Device Problem Information; Excessive Heating; Insufficient Device Problem Information; Excessive Heating

  IT WAS REPORTED THAT DURING AN OT CASE SIMULATION WITH THE ILED 7 CEILING TRIO LIGHTS, ONE OF THE NURSE WAS ON THE OPERATING TABLE. THE LIGHT WAS SET AT 100% INTENSITY, COLOUR TEMPERATURE 5000K, SHINING ON THE NURSED KNEE, WHO WAS WEARING OT SCRUB. AFTER APPROXIMATELY 6 TO 10 MINUTES, THE NURSE FELT DISCOMFORT ON THE KNEE, AND WHEN THEY ROLLED UP THE SCRUB, THEY FOUND THERE WAS REDNESS ON THE KNEE. NO MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050492 ↗
• MalfunctionDec 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LIGHT HEAD OF THE ILED 7 SURGICAL LIGHT SYSTEM FELL DOWN DURING A SURGICAL PROCEDURE ON THE BACK OF A SURGEON. NO HARM OR IMPACT TO THE 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 18364275 ↗
• MalfunctionOct 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED DURING A CASE, A SCREW FELL OUT OF THE MONITOR HOLDER AND LANDED ON TO THE FLOOR AFTER 3RD PARTY INSTALLED THE MONITORS ON THE CUSTOMERS SYSTEM. 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 15594658 ↗
• MalfunctionSep 30, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER ALLEGED THE LIGHT HEAD WAS DROPPED. THE BIO MED WENT TO SECURE THE LIGHT HEAD TO THE SPRING ARM AND IT FELL TO THE FLOOR. 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 15518513 ↗
• MalfunctionSep 29, 2022Mechanical Problem; Detachment of Device or Device Component; No Apparent Adverse Event; Mechanical Problem; Detachment of Device or Device Component; No Apparent Adverse Event

  THE CUSTOMER REPORTED THE PLATE WITH VESA MONITOR ADAPTER AND HANDPIECE HOLDER FELL DURING CLINICAL ACTIVITY WHICH IS PART OF THE MONITOR HOLDER ADAPTER FROM THE COMPANY CIM. 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 15507924 ↗