| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00308-1 |
| Product Name/Description |
TEAM3A & TEAM3I Fetal Monitor
All Serial Numbers affected
Multiple item numbers
ARTG 116216
(Arjo Australia Pty Ltd - Patient monitor, cardiotocograph) |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
5/04/2023 |
| Responsible Entity |
|
| Reason/Issue |
Huntleigh Healthcare Ltd has become aware of a software vulnerability, which manifests as the fetal monitor’s touch screen freezing. This freeze disables the functions that are being displayed. Whilst the occurrence of this vulnerability is extremely rare and audio remains present throughout the screen freeze, user intervention is required to restart the fetal monitor which may lead to a delay of up to 45 seconds. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to install a software upgrade patch – V19.4.1 on the TEAM3 Fetal Monitors. This is in addition to the previously notified upgrade of V19.4. The upgrade patch will be available to download from the Huntleigh Healthcare website. Further instructions regarding the software are found in the customer letter and supporting documents which will be provided to affected customers. Alternatively preloaded memory sticks with the software and upgrade utilities are available from Huntleigh.
Once the upgrade is complete, customers are advised to return the completed declaration via email to FSN01-23HHL@Arjo.com
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0413 700348 - Karen O'Donnell - Snr QRC Manager (AUS) |