FDA Enforcement
Class II
Ongoing
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Recall: Z-2314-2024
·
Reported July 17, 2024
Enforcement
- Recall Number
- Z-2314-2024
- Event ID
- 94766
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 17, 2024
- Initiation Date
- June 4, 2024
- Classification Date
- July 5, 2024
- Address
- 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States
Description
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Reason
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
Code Info
a) UDI/DI 00887761968400, Serial Numbers: 107565745; b) UDI/DI 00887761968394, Serial Numbers: 107565746, 107592673, 107592675, 108034069
Distribution
Worldwide distribution.
Quantity
5 units