Events

Rappel de SPECTRA OPTIA APHERESIS SYSTEM - MAIN UNIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par TERUMO BCT (CANADA) INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    50981
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-06-29
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Model Catalog: 61000 (Lot serial: All)
  • Description du dispositif
    Spectra Optia Apheresis System
  • Manufacturer
    TERUMO BCT (CANADA) INC.

Manufacturer

TERUMO BCT (CANADA) INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    HC