Events

Recall of SPECTRA OPTIA APHERESIS SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TERUMO BCT (CANADA) 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
    50981
  • Event Risk Class
    II
  • Event Initiated Date
    2012-06-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    This notice is to inform you of a situation with the spectra optia system's return line air detector (rlad) that may have an impact on spectra optia procedures. the spectra optia system has experienced a low number of failures of the rlad that have resulted in a non-continuable alarm condition. this impacts all machines with software version 5 and higher. the software version is identified on the screen of the device upon power up. if air is detected falsely due to an rlad failure during a procedure a continuous "air detected in the 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 a procedure to be performed until serviced. no serious injury or death has been associated with these failures. we do not believe this is a disposables related issue.

Device

SPECTRA OPTIA APHERESIS SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 61000 (Lot serial: All)
  • Product Description
    Spectra Optia Apheresis System
  • Manufacturer
    TERUMO BCT (CANADA) INC.

Manufacturer

TERUMO BCT (CANADA) INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    HC