FDA-Device2024-07-17Class II
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
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
275 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2313-2024More Baxter Healthcare Corporation recalls
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