FDA Device recall Z-2315-2024
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light)
- FDA Device
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light) by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2315-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-04 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)
Reason
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
Identifiers
| code_info | All Serial Numbers: a) UDI/DI 00887761968325; b) UDI/DI 00887761968318; c) UDI/DI 00887761968301; d) UDI/DI 008877…All Serial Numbers: a) UDI/DI 00887761968325; b) UDI/DI 00887761968318; c) UDI/DI 00887761968301; d) UDI/DI 00887761968295; e) UDI/DI 00887761968288; f) UDI/DI 00887761968271 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2315-2024%22
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