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
    69661
  • Event Risk Class
    II
  • Event Initiated Date
    2017-05-01
  • 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
    A power filter cable a component used in the internal electrical system had a visible defect which caused the unit to lose power. further evaluation determined that this defect may be present in other electrical cables which could cause a similar non-recoverable power failure. the cables have been isolated to specific manufacturing lots.

Device

SPECTRA OPTIA APHERESIS SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 61000 (Lot serial: 1P04028 TO 1P04392)
  • Product Description
    SPECTRA OPTIA APHERESIS SYSTEM - MAIN UNIT
  • Manufacturer
    TERUMO BCT (CANADA) INC.

Manufacturer

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