iLEDRecalls & reported problems across all models

We found 5 models of iLED by Baxter Medical Systems GmbH + Co. KG in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Jul 8, 2020 and Mar 30, 2026 — classified as 8 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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. 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

Most reported iLED problems

iLED models

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

• iLED 4068210

  Lamp, operating-room
  12 reports
• iLED 4028210

  Lamp, surgical
  10 reports
• iLED 4028310

  Light, surgical, instrument
  9 reports
• iLED 4068310

  Lamp, operating-room
  8 reports
• iLED 4028110

  Light, surgical, instrument
  2 reports

Recent iLED adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Detachment of Device or Device Component

  BAXTER RECEIVED A REPORT THAT ILED7 TRIO/QUAD HAD SPRING ARM FALLING OFF THE CENTER AXIS. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736185 ↗
• 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 ↗
• MalfunctionFeb 28, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE CUSTOMER ALLEGED THAT DURING A SURGICAL PROCEDURE, THE ILED SURGICAL LIGHT SYSTEM BURNED A PATIENT. FOLLOW-UP WITH THE CUSTOMER FOUND THAT THE BURN WAS REPORTED TO BE A FULL THICKNESS BURN AND ¿WOULD REQUIRE ADDITIONAL SURGERY TO MANAGE THE BURN. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 21490523 ↗
• 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 ↗
• MalfunctionApr 5, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT WHEN THE FACILITY MANAGER EXPERIMENTED THE ILED 7 CEILING TRIO LIGHTS ON HIMSELF HE FELT WARM UNDER THE OT SCRUB AND OBSERVED REDNESS AFTER 20 MINS. IT WAS NOTED THAT THE 3 LIGHTS WERE BEING USED AT THE SAME TIME, AND SET AT 100% INTENSITY AND 5000K COLOUR TEMPERATURE. NO MEDICAL INTERVENTION WAS REQUIRED. DURING FOLLOW-UP WITH THE CUSTOMER, IT WAS NOTED THAT THE CUSTOMER WAS UNAWARE OF THE REMAINING RISK ASSOCIATED WITH THE OVERLAPPING OF 2 OR MORE LIGHTS. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051040 ↗
• MalfunctionApr 5, 2024Insufficient Device Problem Information; Excessive Heating; Insufficient Device Problem Information; Excessive Heating

  IT WAS REPORTED THAT DURING AN OT CASE SIMULATION WITH THE ILED 7 CEILING TRIO LIGHTS, ONE OF THE NURSE WAS ON THE OPERATING TABLE. THE LIGHT WAS SET AT 100% INTENSITY, COLOUR TEMPERATURE 5000K, SHINING ON THE NURSED KNEE, WHO WAS WEARING OT SCRUB. AFTER APPROXIMATELY 6 TO 10 MINUTES, THE NURSE FELT DISCOMFORT ON THE KNEE, AND WHEN THEY ROLLED UP THE SCRUB, THEY FOUND THERE WAS REDNESS ON THE KNEE. NO MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050492 ↗
• MalfunctionDec 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LIGHT HEAD OF THE ILED 7 SURGICAL LIGHT SYSTEM FELL DOWN DURING A SURGICAL PROCEDURE ON THE BACK OF A SURGEON. NO HARM OR IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364275 ↗
• 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 ↗

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
• iLED7 Surgical Light6 models · 11 reports · 1 recall
• TL 5000/3000 – Surgical Light2 models · 2 reports · 1 recall
• VidiaPort3 models · 1 reports · 1 recall