| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01007-1 |
| Product Name/Description |
Ambu aView 2 Advance
Catalogue Number: 405011000, 405011000AUS1, 405011000AUS2
All versions and lot numbers
ARTG 405973 & 337704 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Ambu has received information on two incidents where Ambu aView 2 Advance has caught fire when mounted on the VESA interface of an Ambu ‘aCart Compact’ medical workstation.
This was found to be due to screws which were used having entered the lithium-ion battery of the device.
No patients or staff members were harmed during these incidents. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should note that Ambu is not removing any Ambu aView 2 Advance from the field; devices remain available for use. Customers need to be aware if the following warning:
Use only M4 screws with the length of 14 – 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.
Please note that when the Ambu aView 2 Advance is placed on a table or mounted on an IV pole, as per recommended practice, there is no risk of penetrating the battery or of the associated fire hazards.
Please communicate this information to relevant personnel within their organisation. |
| Contact Information |
(02) 9998 1000
1300 233 118 - Brett Wesney. |