FDAJune 4, 2024device
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)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Ongoing
Brands named
baxter healthcarebaxter
UPCs
008877619683250088776196831800887761968301008877619682950088776196828800887761968271
Recall history
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