iLED7 Surgical Light
iLED 7 Mobile
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
Record
| Listed by | Baxter Medical Systems GmbH + Co. KG, Germany |
|---|---|
| FDA product code | FSS |
| Device type | Light, Surgical, Floor Standing |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-01-05 |
| Record revised | 2025-06-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-04-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4068120 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maquet Rolite | Maquet Gmbh | 35 |
| StarTrol | Huot Instruments, LLC | 9 |
| HarmonyAIR | Steris Corporation | 6 |
| Aesculap | Aesculap AG | 5 |
| Lucea LED® | Maquet Gmbh | 4 |
| Amtai | Amtai Medical Equipment, Inc. | 4 |
| Nico Myriad-LX | Nico Corporation | 3 |
| Sunoptic Technologies | Sunoptic Technologies, LLC | 3 |
| Aurora Surgical Light Series | Skytron, LLC | 2 |
| Maxx Luxx LED 160 | Avante | 2 |
| MS Sim.LED OpL wDB | S.i.m.e.o.n. Medical GMBH & Co.KG | 2 |
| STARLED3 NX | Acem SPA | 2 |
Showing 12 of 37. All products under Light, Surgical, Floor Standing
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2024-06-04 | Class II | Under Investigation by firm | 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 a | 6243 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.