Events

Recall of Zymed Holter Converter (Cardiology information system designed for the collection and management of electrocardiography data)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fujifilm Australia 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-01361-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01361-1
  • 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 potential problem with the zymed holter converter if more than one instance of the program was inappropriately started, the pdf image for patient could be generated incorrectly.This recall action was undertaken prior to agreement of the recall strategy by the tga.
  • Action
    Epiphany Healthcare (the manufacturer) installed a software patch to correct the software error.

Device

Zymed Holter Converter (Cardiology information system designed for the collection and management ...
  • Model / Serial
    Zymed Holter Converter (Cardiology information system designed for the collection and management of electrocardiography data)ARTG number: 171621
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd