Ambu aView 2 Advance Monitor Recalled Due to Battery Combustion Risk
Ambu Inc. is recalling the aView 2 Advance Monitor because multiple impacts can cause the device to short-circuit and potentially combust the lithium-ion battery, resulting in smoke and flames.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with potential for fire hazard from lithium-ion battery combustion. However, no injuries, deaths, or property damage have been reported. The hazard requires specific conditions to manifest, making it a risk-of-harm product where actual harm has not yet been reported.
Plain-English summary
Ambu Inc. is recalling the Ambu aView 2 Advance Monitor, a portable endoscopy system display intended to show live imaging from compatible Ambu visualization devices. The recall affects 2,689 units manufactured prior to October 29, 2020, with specific firmware versions 054 through 056 and 058 through 059 (UDI: 5707480145089).
Multiple impacts, such as the device being dropped, can cause the monitor to short-circuit. Under special circumstances, this can lead to combustion of the lithium-ion battery, resulting in smoke and flames.
The affected devices have been distributed nationwide.
Consumers with an affected unit should contact Ambu Inc. for further information and instructions.
The recalled product
- 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
- Manufacturer
- Ambu Inc.
- Affected units
- 2,689
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI: 5707480145089 Version no.: 054 thru 056
- 058 thru 059 Product manufactured prior to Oct 29
- 2020
Distribution
Distributed nationwide across the United States.
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