Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualizat

FDA device recall Z-2628-2023 · posted 2023-09-22 · Open, Classified

Recall details

Recalling firm

Ambu Inc.

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

Action taken

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 be read and kept together with Instruction for Use you received together with your Ambu aView" 2 Advance. The information is also included in Appendix 2 of this notice. Ambu A/S is not removing any Ambu aView 2" Advance from the field; devices remain available for use. Within one month of receipt of this letter, please return confirmation of receipt of this Field Safety Notice (appendix 1). The traceability system at Ambu indicates that your institution has purchased an Ambu aView" 2 Advance within the affected configurations. You should check the version number and manufacturing date (as indicated above) of your device to identify if you have a potentially affected device within your facility. In the case that your device is related to the earliest configurations of Ambu aView" 2 Advance, you address this by familiarizing yourself with the information in the Instruction for Use insert and keep the insert together with the Instruction for Use. This notice needs to be passed on to all those who this might concern within your organization or to any organization where the devices could have been transferred. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Patient safety remains our highest priority.

Root cause

Device Design

Status

Open, Classified

Product code

FEM

Quantity affected

2689 units

Distribution

Nationwide

Date initiated

2023-07-21

Date posted

2023-09-22

Location

Columbia, MD