Events

Recall of Terumo Advanced Perfusion System 1

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Terumo Cardiovascular Systems Inc.

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
    19175
  • Event Initiated Date
    2015-09-25
  • 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: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
  • Reason
    Terumo cardiovascular systems (terumo cvs) has become aware that under certain circumstances, a terumo® advanced perfusion system 1 centrifugal pump "service pump" message may display due to user induced motor movement., in this instance, the terumo system 1 will recognize the movement (as it is designed to do) and display a "service pump" message. the user might interpret this message as a pump that requires service rather than a message displayed due to pump movement while not activated.
  • Action
    Instructions for use to be updated

Device

Terumo Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Inc