Recall Z-2628-2023— Ambu Inc.
Class II · Ongoing
Class II FDA medical device recall by Ambu Inc., initiated 2023-07-21. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Ambu Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-21
- Firm location
- Columbia, MD, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.