FDA Device recall Z-2628-2023
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portab…
- FDA Device
- Class II
- ongoing
- Published 2023-10-04
On 2023-10-04 the FDA classified a Class II recall of Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portab… by Ambu, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2628-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-21 |
| Published | 2023-10-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ambu |
| Distribution | US |
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
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
Identifiers
| code_info | UDI: 5707480145089 Version no.: 054 thru 056; 058 thru 059 Product manufactured prior to Oct 29, 2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2628-2023%22
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