Events

Recall of Terumo Spectra Optia Apheresis System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Terumo BCT 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
    19096
  • Event Initiated Date
    2015-09-04
  • 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: The Business Advisory Group Ltd, Level 13, 34 Shortland St, Auckland 1010
  • Reason
    The manufacturer has received reports of data entry errors that cause the system to calculate a patient total blood volume (tbv) that is abnormal for that specific patient., if the operator does not enter correct data the patient may receive excess anticoagulant (ac) or the outcome of the procedure may be affected.
  • Action
    Software to be upgraded

Device

Terumo Spectra Optia Apheresis System
  • Model / Serial
    Model: Optia, Affected: All serial numbers
  • Manufacturer
    Terumo BCT Inc

Manufacturer

Terumo BCT Inc