Events

Recall of HypoMon Alarm System (alarm for sleep time hypoglycemic episodes)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AIMEDICS Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00755-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00755-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The hypomon is not detecting hypoglycemic events at the required levels as indicated in the instructions for use (ifu).
  • Action
    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 .

Device

HypoMon Alarm System (alarm for sleep time hypoglycemic episodes)
  • Model / Serial
    HypoMon Alarm System (alarm for sleep time hypoglycemic episodes)Serial Numbers: All serial numbers produced in 2012/2013ARTG Number: 200679
  • Manufacturer
    AIMEDICS Pty Ltd

Manufacturer

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