Events

Recall of Nihon Kohden Defibrillator (semi-automated defibrillator)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AHC Solutions 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-2012-RN-01087-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01087-1
  • 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
    When the defibrillator operates on battery and the remaining battery power is almost zero, the battery mark becomes '0', the charge battery message appears and an alarm sounds. if this occurs and the battery isn't replaced with a charged battery or the defibrillator is not connected to ac power, the mother board might become damaged and the defibrillator may not work.
  • Action
    A software update will be implemented for the affected devices.

Device

Nihon Kohden Defibrillator (semi-automated defibrillator)
  • Model / Serial
    Nihon Kohden Defibrillator (semi-automated defibrillator)Model numbers: TEC 5521 & TEC 5531ARTG Number: 172594
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd