Health product recall

Ambu aView 2 Advance

Brand(s)
Last updated

Summary

Product
Ambu aView 2 Advance
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Ambu aview 2 Advance All lots. 405011000 405011000US1 405011000US2

Issue

Ambu has received information on two incidents where Ambu® aView™ 2 Advance caught fire when mounted on the vesa holder of the aCart™ compact, due to incorrect length screws used penetrating the lithium-ion battery of the device. Investigations have identified that the fire hazard was a direct consequence of a battery short-circuit, which, in turn, was triggered by the use of excessively long screws to mount the device. There is no instruction for mounting in the IFU accompanying the device.

Recall Start Date: November 18, 2023

 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Ambu A/S

Baltorpbakken 13, Ballerup, Denmark, 2750

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74680