Baxter iLED 7 surgical lights recalled due to thermal burn risk
Baxter Healthcare is recalling iLED 7 surgical lights due to customer reports of thermal skin injuries. The recall affects approximately 6,243 units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall with explicitly reported thermal skin injuries. The rubric indicates FDA Class II recalls with reported significant injuries warrant a Severe rating.
Plain-English summary
Baxter Healthcare Corporation is recalling iLED 7 surgical light systems because customers have reported thermal skin injuries when using these products. The recall affects six models of surgical lights—Ceiling Single, Mobile, Pendant, Ceiling Duo, Ceiling Trio, and Ceiling Quad—as well as specific VidiaPort and Trulight product codes equipped with iLED 7 light-heads.
A total of 6,243 units have been distributed worldwide. More information about this recall is available from the FDA and Baxter Healthcare Corporation.
The recalled product
- 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
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 6,243
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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