iLED7 Surgical Light 4068310Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887761968288), received between Apr 8, 2024 and Feb 18, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 4, 2024Open, Classified

   Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads

   Z-2315-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT SUSTAINED A BURN WITH AN ILED7 SURGICAL LIGHT. THE PATIENT WAS UNDERGOING A THREE-HOUR THYROID SURGICAL PROCEDURE WHEN A 1.5X1CM PINK AREA ¿JUST BELOW THE SURGICAL AREA¿ WAS OBSERVED TO HAVE DEVELOPED. THE AREA EVOLVED DURING THE CONTINUED PROCEDURE, INTO AN AREA DESCRIBED AS ¿DOUBLING IN SIZE¿ AND ¿OOZING.¿ THE WOUND WAS LATER DESCRIBED A ¿3X2CM BURN THAT WAS PINK AND OOZING.¿ THE ¿PINK AREA¿ HAD AN ABSENT OUTER EPIDERMAL LAYER INDICATIVE OF A SECOND-DEGREE/PARTIAL THICKNESS BURN. NO SPECIFIC MEDICAL TREATMENT WAS REPORTED; HOWEVER, IT WAS REPORTED THAT THE BURN INJURY REQUIRED REPOSITIONING AND FOLLOW-UP WITH A HEALTHCARE PROVIDER. THE CUSTOMER ATTRIBUTES THE INJURY TO THE USE OF TWO LAMPS AT 80% BRIGHTNESS NOT BEING SEPARATED, BUT FIXED (OVERLAPPING). THE LIGHTS WERE NOT FOCUSED ON THE PATIENT BUT ON THE SURGICAL FIELD. ADDITIONAL INFORMATION RECEIVED NOTED THAT MULTIPLE NON-BAXTER HEADLIGHTS WERE USED IN CONJUNCTION WITH THE ILED LIGHTS. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24381640 ↗
• InjuryJul 21, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED AN ILED 7 CEILING TRIO BURNED A PATIENT. THE PATIENT WAS UNDERGOING A RIGHT PARTIAL KNEE REPLACEMENT IN THE OPERATING ROOM. THE PROCEDURE LASTED ONE AND A HALF HOURS IN WHICH THREE ILED LIGHTS WERE UTILIZED. THE PATIENT HAD A HISTORY OF ¿SENSITIVE SKIN¿. WHEN THE SURGICAL DRAPE (IOBAN) WAS REMOVED, THE PATIENT¿S SKIN WAS REMOVED ALONG WITH THE ADHESIVE IOBAN DRAPE. THE PATIENT REPORTEDLY HAD A ¿TEACUP SIZE AND SHAPE BURN AT THE TOP OF THE SURGICAL INCISION SITE.¿ THE CUSTOMER DESCRIBED THE BURN AS ¿A FULL THICKNESS BURN WITH TISSUE NECROSIS.¿ THE PATIENT WAS PROVIDED WITH AN UNKNOWN OINTMENT AND IN HOME WOUND CARE. THE CUSTOMER REPORTED THAT THE TREATMENT FOR THE PATIENT¿S BURN IS ONGOING, AND THAT THE PATIENT MET WITH A PLASTIC SURGEON AND ¿WILL LIKELY NEED SURGERY FOR WOUND DEBRIDEMENT¿ IN THE FUTURE. WARNINGS INCLUDE OVERLAPPING FIELDS OF ILLUMINATION OF SEVERAL LAMP HEADS WITH HIGH LIGHTING INTENSITIES CAN CAUSE TISSUE DAMAGE. THE IFU STATES ¿OVERLAPPING FIELD OF ILLUMINATION OF SEVERAL LAMP HEADS WITH HIGH LIGHTING INTENSITIES CAN CAUSE TISSUE DAMAGE. WITH EARLY ONSET OF TISSUE DEHYDRATION, SEPARATE THE OVERLAPPING FIELDS OF ILLUMINATION OF MULTIPLE LAMP HEADS

  Patient problems: Burn(s)

  MAUDE report 22554219 ↗
• MalfunctionSep 24, 2024Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS INITIALLY REPORTED THAT ON 8/30/2024 THE HOSPITAL STAFF USED ALL THREE ILED 7 LIGHT HEADS AT MAXIMUM INTENSITY FOR ONE SURGICAL SITE FOR A PROCEDURE THAT WAS ABOVE AVERAGE IN DURATION. THE STAFF NOTICED THE IMPACT ON THE SKIN AT THE SITE DURING THE CLOSURE. DURING FOLLOW-UP WITH THE OR MANAGER, IT WAS NOTED THAT A SIMILAR EVENT HAD OCCURRED ON THE SAME DAY WITH ANOTHER PATIENT AND DIFFERENT ILED 7 LIGHTS. THIS SECOND EVENT OCCURRED IN A DIFFERENT OPERATING ROOM, AND WITH A DIFFERENT SURGEON. THE OR MANAGER DESCRIBED THE PATIENTS¿ INJURIES AS SIMILAR, AND PRESENTING SKIN DISCOLORATION, REDNESS, BLISTERING, AND HOT TO TOUCH. SHE STATED THIS RESULTED IN CHANGES IN POST-OP MANAGEMENT AND POST-OP DRESSINGS EMPLOYED. THE OR NURSE ALSO CONFIRMED THE EVENT DID NOT RESULT IN DELAYED HOSPITALIZATION, AND THAT BOTH PATIENTS HAD BEEN DISCHARGED. THIS REPORT ASSESS THE INJURY OCCURRED TO PATIENT #2 IN OPERATING ROOM 7. THE OPERATING ROOM NURSE REPORTED THE INJURY WAS ON THE PATIENT'S CHEST AND 3X3 CENTIMETERS IN SIZE. IT WAS NOTED THE SURGEON DECIDED TO ADD A NON-ADHERING PRIMARY WOUND DRESSING (ADAPTIC) TO THE USUAL POST-OP DRESSING. THE OPERATING ROOM NURSE COULD NOT CONFIRM IF THE INJ

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 20293423 ↗
• InjurySep 24, 2024Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS INITIALLY REPORTED THAT ON (B)(6) 2024, THE HOSPITAL STAFF USED ALL THREE ILED 7 LIGHT HEADS AT MAXIMUM INTENSITY FOR ONE SURGICAL SITE FOR A PROCEDURE THAT WAS ABOVE AVERAGE IN DURATION. THE STAFF NOTICED THE IMPACT ON THE SKIN AT THE SITE DURING THE CLOSURE. DURING FOLLOW-UP WITH THE OR MANAGER, IT WAS NOTED THAT A SIMILAR EVENT HAD OCCURRED ON THE SAME DAY WITH ANOTHER PATIENT AND DIFFERENT ILED 7 LIGHTS. THIS SECOND EVENT OCCURRED IN A DIFFERENT OPERATING ROOM, AND WITH A DIFFERENT SURGEON. THE OR MANAGER DESCRIBED THE PATIENTS¿ INJURIES AS SIMILAR, AND PRESENTING SKIN DISCOLORATION, REDNESS, BLISTERING, AND HOT TO TOUCH. SHE STATED THIS RESULTED IN CHANGES IN POST-OP MANAGEMENT AND POST-OP DRESSINGS EMPLOYED. THE OR NURSE ALSO CONFIRMED THE EVENT DID NOT RESULT IN DELAYED HOSPITALIZATION, AND THAT BOTH PATIENTS HAD BEEN DISCHARGED. THIS REPORT ASSESS THE INJURY OCCURRED TO PATIENT #1 IN OR5. THE OR NURSE REPORTED THE INJURY WAS ON THE PATIENT'S CHEST AND 2X2 CENTIMETERS IN SIZE. IT WAS NOTED THE SURGEON DECIDED TO ADD A NON-ADHERING PRIMARY WOUND DRESSING (ADAPTIC) TO THE USUAL POST-OP DRESSING. THE OR NURSE COULD NOT CONFIRM IF THE INJURY WAS CATEGORIZED AS SECOND OR T

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 20293401 ↗
• MalfunctionApr 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING THE USE OF THE ILED SURGICAL LIGHT, THE LIGHT'S SCREWS FROM THE LAMP HEAD MOUNT FELL DURING THE PROCEDURE AND FELL INTO THE SURGICAL FIELD (IN PATIENT). THE CUSTOMER CONFIRMED THAT NO INJURY OCCURRED, THE SCREW WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO IMPACT TO THE PATIENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067513 ↗