Events

Recall of Spectra Optia Apheresis SystemAll Serial Numbers

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-2012-RN-00924-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00924-1
  • 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
    The manufacturer has become aware that the spectra optia system's return line air detector (rlad) can potentially fail as a result in a non-continuable alarm condition. if air has been falsely detected due to a defective rlad during a procedure, a continuous "air detected in return line" alarm will occur and will not allow the procedure to continue. if the rlad experiences a defect during prime, the system will generate a "return line air detector failed fluid check" alarm and will not allow the procedure to be performed until serviced.
  • Action
    Terumo BCT is providing work around instructions for users to follow.

Device

Spectra Optia Apheresis SystemAll Serial Numbers

Manufacturer

Terumo BCT Australia Pty Ltd