Events

Recall of McKesson Horizon Cardilogy Hemodynamics system

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medcon 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
    16936
  • Event Initiated Date
    2014-07-07
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 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
    Instructions for use to be updated

Device

McKesson Horizon Cardilogy Hemodynamics system
  • Model / Serial
    Model: Models: PB1000 & PB2000, Affected: , Software version: Versions 12.2 HF4 and earlier
  • Manufacturer
    Medcon Ltd

Manufacturer

Medcon Ltd