iLED7 Surgical Light
iLED 7 Ceiling Duo
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Qufu Lekang Medical Technology Group Co., Ltd. | Jining | Shandong | Manufacturer | 7 |
| Shandong Chenhong Medical Technology Co., Ltd. | Jining | Shandong | Manufacturer | 7 |
| Shenzhen Shanglaite Electronic Technology Co., Ltd. | Shenzhen | Guangdong | Remanufacturer | 4 |
| Zhejiang Fude Medphotonic Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 4 |
| Shenzhen Yinghuada Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Baxter Medical Systems GmbH + Co. KG, Germany |
|---|---|
| FDA product code | FSQ |
| Device type | Light, Surgical, Instrument |
| 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 |
|---|---|---|
| 4068210 | Withdrawn | |
| 4068140 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spotlight | Depuy Spine, Inc. | 9 |
| TruLight | Baxter Medical Systems GmbH + Co. KG | 9 |
| iLED | Baxter Medical Systems GmbH + Co. KG | 3 |
| Rutilight | Swan Medical SL | 1 |
| Sterilizable Handles | Baxter Medical Systems GmbH + Co. KG | 1 |
| TL 5000/3000 → Surgical Light | Baxter Medical Systems GmbH + Co. KG | 1 |
| Neo Surgical Lights | NEO Medical Inc. | 1 |
| Rutiside | Swan Medical SL | 1 |
| Rutilight power supply | Swan Medical SL | 1 |
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.