Reported Oct 4, 2023 · Ongoing
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu…
Ambu Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ambu Inc. · 6721 Columbia Gateway Dr Ste 200 · Columbia, MD · 21046-3380
Is this the product you have?
- Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system
- Catalog No405011000
- Lot codes and dates
- UDI5707480145089 Version no.: 054 thru 056; 058 thru 059 Product manufactured prior to Oct 29, 2020
- Amount recalled
- 2689 units
Where it was sold
- Nationwide
Why it was recalled
Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames
This product could cause temporary or reversible health problems — stop using it.
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