FDAClass IIOctober 4, 2023

Ambu aView 2 A Monitor-The Ambu aView 2 Advance is recall

Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable…

Why was Ambu aView 2 A Monitor-The Ambu aView 2 Advance is 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 5707480145089 Version no.: 054 thru 056; 058 thru 059 Product manufactured prior to Oct 29, 2020

Product
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable…
Recalling firm
Ambu Inc.
Quantity
2689 units
Distribution
Nationwide
Recall date
October 4, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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