Events

Recall of Horizon Cardiology Hemo1 – versions 12.2 HF4 and earlier(used for acquiring, displaying and reviewing haemodynamic parameters (vital signs) in cardiac catheterisation laboratories)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2014-RN-00735-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00735-1
  • 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
    Mckesson has identified that its communication to customers regarding the required maintenance tests was insufficient. while each unit has an attached sticker indicating the date of the next maintenance test the need for performing annual maintenance testing is not reiterated in 12.2 hf4 and earlier versions of the horizon cardiology hemo user guides. if the parameter boxes are not calibrated, the horizon cardiology hemo system may not function properly or potentially affect the accuracy of clinical parameters.
  • Action
    Users are advised that the new version of the User Guide (12.2 version 5.0) is now available to address this issue and will be provided electronically upon request. The attachment provided with the customer letter identifies the updated sections of the new User Guide related to annual maintenance testing. This action has been closed-out on 02/02/2016.

Device

Horizon Cardiology Hemo1 – versions 12.2 HF4 and earlier(used for acquiring, displaying and revie...
  • Model / Serial
    Horizon Cardiology Hemo1 – versions 12.2 HF4 and earlier(used for acquiring, displaying and reviewing haemodynamic parameters (vital signs) in cardiac catheterisation laboratories)ARTG number: 146573
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd