| 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 |