Type of Product |
Medical Device |
TGA Recall Reference |
RC-2024-RN-00376-1 |
Product Name/Description |
fabian HFO Classic and fabian HFOi Neonatal and Pediatric Ventilators
fabian HFO Classic Model Number: 112001
UDI: 17640140860203
Software Version: SW v5.2.2.
fabian HFOi
Model Number: 113001
UDI: 17640140860043
Software Version: SW v5.2.2.
ARTG 185053 (Emergo Asia Pacific Pty Ltd T/a Emergo Australia- Ventilator, neonatal/paediatric) |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
14/05/2024 |
Responsible Entity |
|
Reason/Issue |
Ventilation in HFO mode may result in potential false “Patient Disconnect” Alarm. As part of FSCA-21-003, SW V5.2.2 changed the criteria for detecting a patient circuit disconnect during HFO ventilation with the intent to reduce the potential for patient safety-related risks.
This is a follow up action to RC-2023-RN-00445-1 |
Recall Action |
Product Defect Correction |
Recall Action Instructions |
Customers are to: - Download the software release package 5.2.3. Note: Designated individuals within each distributor will receive an email message from Vyaire FTP with the title Important Message – Fabian 5.2.3 – Package Download Link, which will contain links to download the software package, IFUs, and the Technical Bulletin TB-0060, Release of Software Version 5.2.3, from Vyaire Medical Inc.’s secure FTP server. The Technical Bulletin will provide detailed information on how to download and install the software package. - Install the software upgrade according to the upgrade instructions. - Perform calibration and testing according to the test instructions. |
Contact Information |
02 9006 1662 - Emergo Australia |