Events

Recall of Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)

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-00962-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00962-1
  • 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 manufacturer has identified two scenarios in which the mckesson cardiology hemo calculation section incorrectly converts the haemoglobin value before it is utilized in the applicable formula calculations. as a result, the formula output is incorrect. if the issue occurs, then for those procedures that use the specified formula calculations, the formula outputs will be incorrect. this may lead to delay in appropriate treatment or incorrecttreatment.
  • Action
    McKesson will provide a resolution to this issue through a software update. A system check will also take place to identify any previous procedure calculations that may have been affected in your facility. Until the correction is completed additional procedures to ensure correct Hb values are requested to be carried out by end users. This action has been closed-out on 07/06/2016.

Device

Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)
  • Model / Serial
    Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)ARTG Number: 146573
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd