Recall Z-2628-2023 ยท FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)
Ambu Inc.
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
| Date | Sep 22, 2023 (initiated Jul 21, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Device Design |
| Action | Ambu Inc. (US Distirbutor) issued Urgent Field Safety Notice Instruction for Use update for aView 2 Advance on July 21, 2023 delivered via sales representative. Letter states reason for recall, health risk and action to take: The information in this Field Safety Notice is therefore only related to the earliest configurations (versions) of Ambu aView" 2 Advance as listed above. Please communicate this information to relevant personnel within your organization. Included with the Field Safety Notice, you will find an insert for the Instruction for Use for Ambu aView" 2 Advance. The insert should |
| Quantity | 2689 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.