iLED7 Surgical Light 4068210Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887761968295), received between Dec 9, 2024 and Feb 18, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Excessive Heating” (1 report).

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 3 most recent of 3 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 24381735 ↗
• InjuryAug 26, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED AN ILED 7 CEILING DUO BURNED A PATIENT. DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGICAL TEAM FOUND THE PATIENT¿S SKIN WAS ¿LIKE PEELING AT BACK OF THE PATIENT¿ AND TEMPERATURE WHERE THE LIGHT WAS FOCUSED ON THE PATIENT¿S BACK WAS HOTTER COMPARED TO THE OTHER PARTS OF THE PATIENT¿S BODY. THE PATIENT WAS TREATED WITH COLD FLUIDS APPLIED TO THE AFFECTED AREA. THE BIOMEDICAL DEPARTMENT DID AN INVESTIGATION BY FOCUSING THE LIGHT ON ONE SPOT AND FOUND THAT THE AREA WHERE IT WAS FOCUSED ON WAS HOT AND REACHED A TEMPERATURE OF 43 DEGREES CELSIUS. THE LIGHT DEFAULT NORMAL SETTINGS ARE 50%; HOWEVER, THE OPERATING ROOM TEAM CAN INCREASE THEM DURING THE PROCEDURE IF NEEDED. THE BAXTER TECHNICIAN CHECKED THE SOFTWARE OF THE LIGHT AND FOUND THAT ALL ARE UP TO DATE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 22895897 ↗
• InjuryDec 9, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN EMPLOYEE WAS INJURED WHILE TRYING TO MOVE THE ILED 7 SPRING ARM. THE SPRING ARM ALLEGEDLY HAD MISSING AND LOOSE PARTS. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 20876973 ↗