Events

Recall of TCVS Heart lung machine

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
    20672
  • Event Initiated Date
    2016-09-22
  • 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
    There have been multiple reports regarding battery capacity issues in which the terumo advanced perfusion system 1 displayed some or all of the following symptoms:, 1. the system displayed false information, indicating battery capacity (i.E. hours/minutes remaining) when the batteries have little or no remaining capacity, 2. the system unexpectedly shut down without warning when running on battery power, 3. batteries were completely depleted, 4. batteries did not retain their charge as intended.
  • Action
    Manufacturer to issue advice regarding use

Device

TCVS Heart lung machine

Manufacturer

Terumo Cardiovascular Systems Inc