Home / Recalls / Baxter Healthcare Corporation / Z-2314-2024

Z-2314-2024 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
July 17, 2024
Initiation Date
June 4, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

Product Description

Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)

Reason for Recall

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

Distribution Pattern

Worldwide distribution.

Code Information

a) UDI/DI 00887761968400, Serial Numbers: 107565745; b) UDI/DI 00887761968394, Serial Numbers: 107565746, 107592673, 107592675, 108034069

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