PlainRecalls
FDA Devices Moderate Class II Ongoing

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 No: 405011000

Reported: October 4, 2023 Initiated: July 21, 2023 #Z-2628-2023

Product Description

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 No: 405011000

Reason for Recall

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

Details

Recalling Firm
Ambu Inc.
Units Affected
2689 units
Distribution
Nationwide
Location
Columbia, MD

Frequently Asked Questions

What product was recalled?
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 No: 405011000. Recalled by Ambu Inc.. Units affected: 2689 units.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on October 4, 2023. Severity: Moderate. Recall number: Z-2628-2023.