Events

Safety Alert for HypoMon Alarm Systems

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by AIMEDICS Pty Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-08-05
  • Event Date Posted
    2013-08-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130805.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: aimedics hypomon alarm systems 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.

Device

HypoMon Alarm Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: AIMEDICS HypoMon Alarm Systems
  • Manufacturer
    AIMEDICS Pty Ltd

Manufacturer

AIMEDICS Pty Ltd
  • Manufacturer Parent Company (2017)
    AiMedics
  • Source
    DH