Home / Recalls / Baxter Healthcare Corporation / Z-2315-2024

Z-2315-2024 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
6243 units

Product Description

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)

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

All Serial Numbers: a) UDI/DI 00887761968325; b) UDI/DI 00887761968318; c) UDI/DI 00887761968301; d) UDI/DI 00887761968295; e) UDI/DI 00887761968288; f) UDI/DI 00887761968271

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