Reported Jul 17, 2024 · Ongoing
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light);…
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
6 of 6 products
| # | Product as published |
|---|---|
| 1 | 4068110 (Ceiling Single Surgical Light) |
| 2 | 4068120 (Mobile Surgical Light) |
| 3 | 4068140 (Pendant Surgical Light) |
| 4 | 4068210 (Ceiling Duo Surgical Lights) |
| 5 | 4068310 (Ceiling Trio Surgical Lights) |
| 6 | 4068410 (Ceiling Quad Surgical Lights) |
- Lot codes and dates
- All Serial Numbers
a) UDI/DI 00887761968325b) UDI/DI 00887761968318c) UDI/DI 00887761968301d) UDI/DI 00887761968295e) UDI/DI 00887761968288f) UDI/DI 00887761968271
- All Serial Numbers
- Amount recalled
- 6243 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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