| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00275-1 |
| Product Name/Description |
G5 Mobile Receiver
Manufactured between January 2016 and February 2017
ARTG Number:169241
(Emergo Asia Pacific T/a Emergo Australia - Glucose monitoring system, in vivo) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
G5 Mobile receivers manufactured between January 2016 and February 2017 may not adequately complete the power on sequence under specific conditions. Specifically, when the receiver is turned on, the green loading bar on the initialization screen becomes stuck with no further progress. The user cannot clear this screen and the receiver cannot be used to track blood glucose values. This is due to a software defect affecting devices produced in the above timeframe, which renders the receiver unusable after shutting it down in a particular sequence. This is a detectable issue for users if they check the screen after turning it on. No adverse health consequences are anticipated if you make sure you have access to an alternative means of monitoring your blood glucose. |
| Recall Action |
Recall |
| Recall Action Instructions |
Emergo is advising users to contact Australian Medical Scientific (AMSL) to obtain a replacement receiver.
Supplemental instructions will be provided to users as an interim measure to prevent this issue occurring until users receiver an updated receiver.
This action has been closed out on 06/11/2018 |
| Contact Information |
02 9006 1662 - Emergo |