iLED7 Surgical Light 4068120Recalls & reported problems
Baxter Medical Systems GmbH + Co. KG · iLED 7 Mobile · Class 2
All models of iLED7 Surgical Light (6)
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
- 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 18, 2026.
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-2315-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Light, surgical, floor standing devices
- HarmonyAIR A-Series Mobile LightSteris Corporation · Light, surgical, floor standing2 recalls0 reports
- LUCEA LED® ARDLCA309005AMaquet Sas · Light, surgical, floor standing1 recall2 reports
- Maquet Rolite ARDROL309031AMaquet Sas · Light, Surgical, Floor Standing1 recall1 report
- LUCEA LED® ARDLCA309007AMaquet Sas · Light, surgical, floor standing1 recall1 report
- Maquet Rolite ARDROL309053AMaquet Sas · Light, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309037AMaquet Sas · Light, Surgical, Floor Standing1 recall0 reports
- Maquet Rolite ARDROL309041AMaquet Sas · Light, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309043AMaquet Sas · Light, surgical, floor standing1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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