FDA recall Z-2628-2023

Product

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

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2023-07-21

Report date

2023-10-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbia, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2628-2023