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VidiaPort Carrying Arm (Baxter) – Thermal Injury Risk (2024)

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

High

FDAJun 4, 2024Nationwide• Baxter Healthcare Corporation

iLED 7 Surgical Lights (Baxter) – Thermal Injury Risk (2024)

High

FDAJun 4, 2024Nationwide• Baxter Healthcare Corporation

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VidiaPort Carrying Arm (Baxter) – Thermal Injury Risk (2024)

iLED 7 Surgical Lights (Baxter) – Thermal Injury Risk (2024)

Mack MD Electric (Mack) – Battery Management Malfunction (2024)

Western Star 47X (Western Star) – Tie Rod Assembly Issue (2024)

Meridian Angled Awl (SeaSpine) – Insufficient Weld (2024)

Trulight 5000/3000 Surgical Light (Baxter) – Thermal Injury Risk (2024)

Beckman Coulter DXL 9000 Analyzer (Beckman Coulter) – Cable Corrosion Risk (2024)

BMW CE2 Motorcycle Side Bag (BMW) – Mounting Holder Problem (2024)

Volvo VN (Volvo) – Steering Gear Plug Defect (2024)

Eszopiclone Tablets (Dr. Reddy's) – Impurity Specifications (2024)

Amoxicillin Chewable Tablets (Teva) – Subpotent Drug (2024)

Kuat Transfer V2 (Kuat) – Bike Rack Pivot Cam Issue (2024)

Forest River Cedar Creek (Forest River) – Electrical Protection Failure (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Bag Decanter II (Microtek Medical) – Packaging Integrity Issue (2024)

Forest River Puma (Forest River) – Side Marker Light Missing (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Gillig Low Floor (Gillig) – Fuel Line Crimping Problem (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

C-Flow Bag Decanter (Microtek Medical) – Packaging Integrity Issue (2024)