Device 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
Z-2628-2023
Product summary
- Firm
- Ambu Inc.
- Event
- Event 92886
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2689 units
- Official record key
device-enforcement:Z-2628-2023
Official wording
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
Code information: UDI: 5707480145089 Version no.: 054 thru 056; 058 thru 059 Product manufactured prior to Oct 29, 2020
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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