The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning HypoMon Alarm Systems manufactured by AIMEDICS Pty Ltd. All serial number produced in 2012 and 2013 are affected.
The HypoMon is not detecting hypoglycemic events at the required levels as indicated in the Instructions for Use. The manufacturer is requesting customers return the affected products.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00755-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 05 August 2013