| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00755-1 |
| Product Name/Description |
HypoMon Alarm System (alarm for sleep time hypoglycemic episodes)
Serial Numbers: All serial numbers produced in 2012/2013
ARTG Number: 200679 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
The HypoMon is not detecting hypoglycemic events at the required levels as indicated in the Instructions For Use (IFU). |
| Recall Action |
Recall |
| Recall Action Instructions |
AIMEDICS is requesting customers return the goods for a full refund of the purchase price. For more details, please see http://www.tga.gov.au/safety/alerts-device-hypomon-130805.htm . |
| Contact Information |
1800 497 666 - HypoMon Customer Service |