Events

Rappel de Spectra Optia Apheresis System - Return Line Air Detector (RLAD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Terumo BCT Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00886-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00886-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Terumo bct has redesigned the return line air detector (rlad) component of the spectra optia apheresis system. this redesign will further reduce the low occurrence of false air detections during a procedure; the plan has been to install the replacement component on devices in which a rlad false air detect has occurred.
  • Action
    Terumo BCT is replacing the existing RLAD sensor with the redesigned component on all Spectra Optia systems in Australia. If false air detections have occurred on a system in the last 12 months the upgrade will be scheduled as soon as possible. Where no issues have been reported the RLAD sensor will be replaced during the next scheduled preventative maintenance visit. This action has been closed-out on 03/05/2016.

Device

Spectra Optia Apheresis System - Return Line Air Detector (RLAD)
  • Modèle / numéro de série
    Spectra Optia Apheresis System - Return Line Air Detector (RLAD)ARTG Number: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd