iLED7 Surgical Light 4068140Recalls & reported problems
Baxter Medical Systems GmbH + Co. KG · iLED 7 Pendant · Class 2
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. How this data works · Data updated Oct 13, 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 · FDA record ↗
Other Light, surgical, instrument devices
- iLED7 Surgical Light 4068210Baxter Medical Systems GmbH + Co. KG · Light, surgical, instrument1 recall3 reports
- iLED 4028310Baxter Medical Systems GmbH + Co. KG · Light, surgical, instrument9 reports
- TruLight 4038210Baxter Medical Systems GmbH + Co. KG · Light, surgical, instrument5 reports
- iLED 4028110Baxter Medical Systems GmbH + Co. KG · Light, surgical, instrument2 reports
- SPOTLIGHT 282950900Depuy Spine, LLC · Light, surgical, instrument1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.