iLED7 Surgical Light 4068410Recalls & reported problems
Baxter Medical Systems GmbH + Co. KG · iLED 7 Ceiling Quad · Class 2
All models of iLED7 Surgical Light (6)
Data updated Oct 16, 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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
- 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 ↗
Other Lamp, operating-room devices
- iLED7 Surgical Light 4068110Baxter Medical Systems GmbH + Co. KG · Lamp, operating-room1 recall3 reports
- TL 5000/3000 – Surgical Light 4038310Baxter Medical Systems GmbH + Co. KG · Lamp, operating-room1 recall1 report
- 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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