Z-2628-2023Class II

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

Name: Z-2628-2023 Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu...
Creator: Ambu Inc.
Published: 2023-07-21
License: https://open.fda.gov/license/

Ambu Inc. / initiated 2023-07-21 / Open, Classified / root cause: design

FDA source

Ambu Inc. began a recall of 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... on 2023-07-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2628-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-21
Posted: 2023-09-22
Recalling firm: Ambu Inc.
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
Product code: FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)
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
Root cause tag: design
FDA 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 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
Product codes and lots: UDI: 5707480145089 Version no.: 054 thru 056; 058 thru 059 Product manufactured prior to Oct 29, 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2628-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2628-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-22

Product code FEM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)