iLED7 Surgical LightRecalls & reported problems across all models

We found 6 models of iLED7 Surgical Light by Baxter Medical Systems GmbH + Co. KG in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Apr 8, 2024 and Feb 18, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (2 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

iLED7 Surgical Light recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 6 of these models · Recall details · FDA record ↗

Most reported iLED7 Surgical Light problems

iLED7 Surgical Light models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• iLED7 Surgical Light 4068310

  Lamp, surgical
  1 recall5 reports
• iLED7 Surgical Light 4068210

  Light, surgical, instrument
  1 recall3 reports
• iLED7 Surgical Light 4068110

  Lamp, operating-room
  1 recall3 reports
• iLED7 Surgical Light 4068410

  Lamp, operating-room
  1 recall0 reports
• iLED7 Surgical Light 4068140

  Light, surgical, instrument
  1 recall0 reports
• iLED7 Surgical Light 4068120

  Light, surgical, floor standing
  1 recall0 reports

Recent iLED7 Surgical Light adverse event reports

The 11 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Baxter Medical Systems GmbH + Co. KG products

• TS 750016 models · 4 reports · 14 recalls
• TRUMPF MEDICAL11 models · 78 reports
• TS 70003 models · 26 reports · 1 recall
• TL 5000/3000 – Surgical Light2 models · 2 reports · 1 recall
• VidiaPort3 models · 1 reports · 1 recall
• iLED5 models · 41 reports