Events

Recall of ICS G2 Clinical Access (used for acquiring 24-72 hours of standard patient waveforms for analysis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtel 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-2014-RN-00418-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-04-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00418-1
  • 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
    There is a defect in the ics g2 clinical access software cd. the programs installed on the clinical access cd are incorrect and will prevent the user from installing clinical access.
  • Action
    Medtel Australia is requesting their customers to dispose of CD: PN 063-1829-11 Rev A and replace with Rev B. The replacement CD will be delivered to all relevant departments of the hospital by a Medtel service engineer.

Device

ICS G2 Clinical Access (used for acquiring 24-72 hours of standard patient waveforms for analysis)
  • Model / Serial
    ICS G2 Clinical Access (used for acquiring 24-72 hours of standard patient waveforms for analysis)CD PN: 063-1829-11 Rev AModel: 91810ARTG Number: 128816
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA