TL 5000/3000 – Surgical Light 4038310Recalls & reported problems
Baxter Medical Systems GmbH + Co. KG · TruLight 5000 / 3000 Ceiling Trio · Class 2
All models of TL 5000/3000 – Surgical Light (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887761968394), received between Jun 3, 2025 and Jun 3, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Reports received per month
Recalls naming this device
- Jun 4, 2024Class IIOpen, 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-2314-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TRULIGHT TRIO HAD AN ISSUE, DUAL MONITOR SUPPORT SEPARATED FROM THE BOOM AND IS RESTING ON THE OPERATING ROOM TABLE. ADDITIONALLY, THE LIGHT FIXTURE SEPARATED FROM THE BOOM AND FELL DAMAGING THE FIXTURE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22132961 ↗
Other Lamp, operating-room devices
- iLED7 Surgical Light 4068110Baxter Medical Systems GmbH + Co. KG · Lamp, operating-room1 recall3 reports
- iLED7 Surgical Light 4068410Baxter Medical Systems GmbH + Co. KG · Lamp, operating-room1 recall0 reports
- iLED 4068210Baxter Medical Systems GmbH + Co. KG · Lamp, operating-room12 reports
- SynFrame 387.345Synthes GmbH · Lamp, operating-room12 reports
- SynFrame 387.338Synthes GmbH · Lamp, operating-room9 reports
- SynFrame 387.343Synthes GmbH · Lamp, operating-room9 reports
- iLED 4068310Baxter Medical Systems GmbH + Co. KG · Lamp, operating-room8 reports
- SynFrame 387.336Synthes GmbH · Lamp, operating-room6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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