iLED7 Surgical Light 4068110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887761968325), received between Jun 12, 2025 and Feb 12, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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 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 7DEVICE 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 A

  Patient problems: Concussion; Head Injury; Pain

  MAUDE report 24329435 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF HEALTHCARE PROFESSIONALS SUSTAINED AN ARRAY OF ¿HEAD INJURIES¿ DUE TO THE HEIGHT OF THE ILED7 SURGICAL LIGHT. IN OPERATING ROOM #6 THE CEILING IS LOW, AND THIS CAUSED THE HEIGHT OF THE ILED SURGICAL LIGHT TO BE LOWER AS WELL. FURTHERMORE, THE NURSES AND SURGEONS HAVE SUSTAINED CONTUSIONS AND HEMATOMAS. ONE NURSE IS ON ¿SICK LEAVE¿ AFTER SUSTAINING AN UNSPECIFIED ¿HEAD INJURY¿ FROM THE IMPACT WITH THE OPERATING LIGHT. THERE WAS NO ALLEGED MALFUNCTION OF THE ILED LIGHT. ADDITIONALLY, THE CUSTOMER CONTINUED TO USE THE ALLEGED ¿LOW LIGHTS¿ POST-INSTALLATION, THUS, USE ERROR CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR TO THE INJURY. FURTHERMORE, PREVENTION OF THIS TYPE OF EVENT IS OUTLINED IN THE DEVICE INSTRUCTIONS FOR USE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bruise/Contusion; Hematoma

  MAUDE report 22194053 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF HEALTHCARE PROFESSIONALS SUSTAINED AN ARRAY OF ¿HEAD INJURIES¿ DUE TO THE HEIGHT OF THE ILED7 SURGICAL LIGHT. IN OPERATING ROOM # 6 THE CEILING IS LOW, AND THIS CAUSED THE HEIGHT OF THE ILED SURGICAL LIGHT TO BE LOWER AS WELL. FURTHERMORE, THE NURSES AND SURGEONS HAVE SUSTAINED CONTUSIONS AND HEMATOMAS. ONE NURSE IS ON ¿SICK LEAVE¿ AFTER SUSTAINING AN UNSPECIFIED ¿HEAD INJURY¿ FROM THE IMPACT WITH THE OPERATING LIGHT. THERE WAS NO ALLEGED MALFUNCTION OF THE ILED LIGHT. ADDITIONALLY, THE CUSTOMER CONTINUED TO USE THE ALLEGED ¿LOW LIGHTS¿ POST-INSTALLATION, THUS, USE ERROR CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR TO THE INJURY. FURTHERMORE, PREVENTION OF THIS TYPE OF EVENT IS OUTLINED IN THE DEVICE INSTRUCTIONS FOR USE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bruise/Contusion; Hematoma

  MAUDE report 22194044 ↗