FDAFDA · Food and drugs·Recall number Z-0714-2024
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Published January 17, 2024 · Recall initiated: December 5, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ambu Inc.
- Distributor
- Domestic distribution nationwide.
- Lot
- Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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