Class 2 Device Recall Ambu

• Date Initiated by Firm: July 21, 2023
• Date Posted: September 22, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2628-2023
• Recall Event ID: 92886
• Product Classification: Accessories, photographic, for endoscope (exclude light sources) - Product Code FEM
• 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
• Code Information: UDI: 5707480145089 Version no.: 054 thru 056; 058 thru 059 Product manufactured prior to Oct 29, 2020
• Recalling Firm/ Manufacturer: Ambu Inc.; 6721 Columbia Gateway Dr Ste 200; Columbia MD 21046-3380
• For Additional Information Contact: SAME; 410-768-6464
• Manufacturer 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
• FDA Determined 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 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.
• Quantity in Commerce: 2689 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.