Events

Recall of Spectra Optia Apheresis System - Return Line Air Detector (RLAD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Terumo BCT 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-00886-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00886-1
  • 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
    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)
  • Model / Serial
    Spectra Optia Apheresis System - Return Line Air Detector (RLAD)ARTG Number: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd