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Ultrasound EA Table (Oakworks) – Backrest Platform Stress (2023)

Backrest platform stress fracture - the table is not operational in an inclined position

High

FDADec 5, 2023Nationwide• Oakworks Inc

Ambu aView 2 A Monitor (Ambu) – Mounting Screw Warning (2023)

Fire/Burn Risk

Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.

High

FDADec 5, 2023Nationwide• Ambu Inc.

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Ultrasound EA Table (Oakworks) – Backrest Platform Stress (2023)

Ambu aView 2 A Monitor (Ambu) – Mounting Screw Warning (2023)

CYF-VHR Videoscope (Olympus) – Cleaning Brush Update (2023)

CYF-5 Cystonephrofiberscope (Olympus) – Cleaning Brush Update (2023)

ENF-XP Rhino-Laryngofiberscope (Olympus) – Cleaning Brush Update (2023)

BF-P190 Bronchovideoscope (Olympus) – Cleaning Brush Update (2023)

CYF-V2R Visera Videoscope (Olympus) – Cleaning Brush Update (2023)

CYF-VH Cysto-Nephro Videoscope (Olympus) – Cleaning Brush Update (2023)

Dover Silicone Foley Tray (Cardinal Health) – Recalled Component (2023)

CYF-V2 Visera Videoscope (Olympus) – Cleaning Brush Update (2023)

Dover Silicone Foley Tray (Cardinal Health) – Recalled Component (2023)

Dover Urine Meter Tray (Cardinal Health) – Recalled Component (2023)

Soltive Laser Fiber Stripper (Olympus) – Sterilization Concern (2023)

Dover Irrigation Tray (Cardinal Health) – Recalled Component (2023)

BF-XP190 Bronchovideoscope (Olympus) – Cleaning Brush Update (2023)

Soltive Laser Fibers (Olympus) – Sterile Pouch Seal (2023)

Dover Silicone Foley Tray (Cardinal Health) – Recalled Component (2023)

Argyle Suction Catheter Tray (Cardinal Health) – Recalled Component (2023)

Trach Kit (Cardinal Health) – Recalled Component (2023)

CYF-5R Cystonephrofiberscope (Olympus) – Cleaning Brush Update (2023)