FDA-Device2024-07-17Class II
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Baxter Healthcare Corporation
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
Sold states
Worldwide distribution.
Affected count
5 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2314-2024Don't want to check this manually?
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