Ambu aView 2 Advance recallZ-2628-2023 · Ambu Inc. · initiated Jul 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ambu Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2628-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 21, 2023
- Posted by the FDA
- Sep 22, 2023
- Recalling firm
- Ambu Inc.
- Quantity
- 2689 units
- Product code
- FEM
- Distribution
- Nationwide
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
Code information (models, lots, serial numbers)
UDI: 5707480145089 Version no.: 054 thru 056; 058 thru 059 Product manufactured prior to Oct 29, 2020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ambu aView™ 2 Advance 405011000Ambu A/S · ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)2 recalls4 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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