iLED 4068210Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887761995857), received between Jan 12, 2022 and Feb 12, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED A SURGEON HIT THEIR HEAD ON AN ILED LIGHT AND SUSTAINED A CONCUSSION. THE SURGEON WAS PERFORMING A PROCEDURE ON A PATIENT WHEN THE PHYSICIAN ¿MOVED TO GET AROUND THE PATIENT'S KNEE¿ AND HIT THEIR HEAD ¿VIOLENTLY¿ ON THE HANDLE/CAMERA OF THE LIGHT FIXTURE. THE SURGEON COMPLAINED OF PAIN AND DIZZINESS. THE SURGEON HAD TO SIT DOWN ¿UNTIL THEY REGAINED THEIR SENSES.¿ THE SURGEON EXPERIENCED PAIN FOR A FEW DAYS IN WHICH THEY TOOK UNSPECIFIED ¿PAIN KILLERS.¿ CURRENTLY THE PHYSICIAN HAS RECOVERED. ADDITIONALLY, IT WAS REPORTED THE SURGEON WAS TALL AND THE OPERATING ROOM ¿THE ILED7 LIGHTS REMAIN TO BE TOO LOW DESPITE THE CHANGE OF THE LIGHTS SPRING ARM FROM NORMAL HEIGHT TO THE ONES DEDICATED FOR LOW CEILINGS¿ IN 2025. THE ILED 7 DEVICE INSTRUCTION FOR USE WARNS ¿A COLLISION INVOLVING THE SUPPORT ARMS OR LAMP HEAD CAN RESULT IN DAMAGE. AVOID COLLISIONS WITH OTHER OBJECTS OR ADJACENT WALLS. BEFORE ADJUSTING THE HEIGHT, CHECK THAT THERE IS SUFFICIENT CEILING CLEARANCE AND ENSURE THAT THERE ARE NO OTHER OBJECTS POSITIONED ABOVE THE LAMP HEAD. FURTHERMORE, THE INSTRUCTIONS FOR USE STATE ¿BEFORE THE MEDICAL DEVICE IS APPLIED, THE USER MUST ENSURE THAT THE PRODUCT IS OPERATIONAL

  Patient problems: Concussion; Head Injury; Pain

  MAUDE report 24329433 ↗
• MalfunctionAug 4, 2025Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  BAXTER RECEIVED A REPORT STATING THAT ILED7 DUO LIGHT HEAD FELL TO THE FLOOR. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699960 ↗
• MalfunctionJun 18, 2024Device Fell; Device Fell

  THE CUSTOMER REPORTED THAT THE ILED 7 SURGICAL LIGHT FELL DOWN TO THE GROUND. 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 19557917 ↗
• InjurySep 27, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT DEVELOPED A BURN DURING A SURGICAL PROCEDURE USING THE ILED 7 SURGICAL LIGHT SYSTEM. THE BURN WAS NOTED TO BE BLISTERS DISTALLY IN SURGICAL INCISION OF THE RIGHT GROIN. MEDICAL INTERVENTION FOR THE BURN WAS REPORTED TO BE THE APPLICATION OF AN ABSORBENT DRESSING. NO FURTHER INTERVENTION WAS REPORTED. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE INJURY APPEARS TO BE A SERIOUS INJURY AND WOULD LIKELY REQUIRE MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF BODY STRUCTURE OR PERMANENT DAMAGE TO BODY FUNCTION, WHICH CONCLUDES A SERIOUS INJURY OCCURRED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 17824653 ↗
• InjurySep 27, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT DEVELOPED A BURN DURING A SURGICAL PROCEDURE USING THE ILED SURGICAL LIGHT SYSTEM. THE BURN WAS NOTED TO BE BLISTERS LATERAL TO SURGICAL INCISION IN THE LEFT KNEE JOINT. MEDICAL INTERVENTION FOR THE BURN WAS REPORTED TO BE THE APPLICATION OF AN ABSORBENT DRESSING. NO FURTHER INTERVENTION WAS REPORTED. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE INJURY APPEARS TO BE A SERIOUS INJURY AND WOULD TYPICALLY REQUIRE MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 17824567 ↗
• InjurySep 21, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS INITIALLY REPORTED THAT A PATIENT SUSTAINED A BURN DURING A SURGICAL PROCEDURE USING THE ILED 7 SURGICAL LIGHT SYSTEM. ADDITIONAL DETAILS RECEIVED DESCRIBED THE BURN AS "BLISTERS TO THE LEFT GROIN DISTAL TO THE SURGICAL INCISION." THE AREA WAS NOTED TO MEASURE 8.18 CM² AND WAS TREATED WITH AN ¿ABSORBENT DRESSING TO KEEP THE WOUND MOIST.¿ NO ADDITIONAL INTERVENTION WAS REPORTED. PER THE INFORMATION PROVIDED, THE BURN SHOWS A LARGE RED AREA CONTAINING THE CHARACTERISTICS OF A RUPTURED BLISTER, INDICATIVE OF A PARTIAL-THICKNESS SECOND TO THIRD-DEGREE BURN. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE INJURY APPEARS TO BE A SERIOUS INJURY AND WOULD TYPICALLY REQUIRE MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 17787264 ↗
• InjurySep 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS INITIALLY REPORTED THAT A PATIENT SUSTAINED A BURN DURING A SURGICAL PROCEDURE USING THE ILED 7 SURGICAL LIGHT SYSTEM. ADDITIONAL DETAILS RECEIVED DESCRIBED THE BURN AS BLISTERS TO THE LEFT GROIN LATERAL TO THE SURGICAL INCISION.¿ THE AREA WAS NOTED TO HAVE BEEN TREATED WITH AN ¿ABSORBENT DRESSING TO KEEP THE WOUND MOIST.¿ NO ADDITIONAL INTERVENTION WAS REPORTED. PER THE IMAGE PROVIDED, THE INJURY IS NOTED TO MEASURE 6 CM² AT 15-46 DAYS POST-OPERATIVE. THE IMAGE SHOWS TWO RAISED OPEN RED AREAS WITH SLIGHT WHITE BLOTCHINESS AND SLIGHT CHARRED EDGES, WITH THE APPEARANCE OF PARTIAL-THICKNESS SECOND TO THIRD-DEGREE BURN. BASED ON THE IMAGE PROVIDED BY THE CUSTOMER, THE INJURY APPEARS TO BE A SERIOUS INJURY AND WOULD TYPICALLY REQUIRE MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

  Patient problems: Burn(s)

  MAUDE report 17787254 ↗
• InjurySep 19, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT DEVELOPED A BURN DURING A 2-3 HOUR SURGICAL PROCEDURE USING THE ILED 7 SURGICAL LIGHT SYSTEM. THE BURN WAS NOTED TO BE A FULL SKIN BURN WITH CHARACTERISTICS REPORTED AS REDNESS MEDIAL TO THE SURGICAL INCISION AND BLISTERING AT AN UNSPECIFIED LATER TIME. THE PATIENT¿S BURN WAS TREATED WITH COOLING BANDAGES AND A PCA (PATIENT-CONTROLLED ANALGESIA) PUMP. BASED ON THE REPORT THAT THE PATIENT SUSTAINED A FULL SKIN BURN AND THE PATIENT REQUIRED MEDICAL INTERVENTION (COOLING BANDAGES AND AN ANALGESIC PUMP) TO POSSIBLY PRECLUDE PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR PERMANENT DAMAGE TO BODY FUNCTION, CONCLUDES A SERIOUS INJURY OCCURRED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #C-2028156.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 17771994 ↗
• MalfunctionJun 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER ALLEGED THAT THE ROOM WAS BEING CLEANED AFTER A CASE. THE CLEANING TECHNICIAN ADJUSTED LIGHT UP TO CLEAN TABLE, A FEW SECONDS LATER THE LIGHT HEAD FELL HITTING THE CLEANING TECH IN THE HEAD AND THEN LIGHT HEAD FELL TO FLOOR. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Concussion

  MAUDE report 17223600 ↗
• InjuryJun 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT DURING USE OF THE ILED7 SURGICAL LIGHTS, THE INTENSITY LEVEL OF THE LIGHTS WAS TOO HIGH AND WHILE CLOSING THE SURGICAL INCISION, THE FELLOW NOTED AN OPEN SORE ON THE PATIENT¿S RIGHT SHOULDER. THE WOUND WAS EXCISED, CLOSED WITH SUTURE AND DRESSINGS APPLIED. DURING A FOLLOW-UP VISIT WITH THE PATIENT, THE WOUND WAS FOUND TO BE HEALING WITHOUT ISSUE. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17115999 ↗
• InjuryJun 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT AT THE END OF THE PROCEDURE WHEN DRAPES WERE TAKEN DOWN IT WAS NOTED THAT THE PATIENT HAD AN APPROXIMATELY 1" LACERATION ON THE RIGHT ANTERIOR LOWER LEG. THE LACERATION WAS CLEANED, SUTURED AND DERMABOND WAS APPLIED. THE LACERATION WAS COVERED WITH TEGADERM, AND THE PATIENT WAS TAKEN TO RECOVERY. THE PATIENT¿S LACERATION HEALED. THE CUSTOMER ALLEGED THE INTENSITY LEVEL OF THE SURGICAL LIGHTS WAS TOO HIGH AND CAUSING THE INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 17115768 ↗
• MalfunctionJan 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER ALLEGED THAT DURING A SURGICAL PROCEDURE THE LIGHT HEAD DETACHED FROM THE SPRING ARM AND FELL ONTO A PATIENT. IT WAS FURTHER STATED THE SURGEON CAUGHT THE LIGHT. NO HARM WAS REPORTED IN RELATION TO THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237563 ↗