Events

Rappel de ADVANCED PERFUSION SYSTEM 1 - BASE UNIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par RYAN MEDICAL DISTRIBUTORS 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
    107089
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-11-30
  • 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
    Terumo cardiovascular systems (terumo cvs) has become aware of a remote possibility that terumo advanced perfusion system 1 could experience a spontaneous loss of power. terumo cvs is issuing this advisory because the user's manual for the terumo advanced perfusion system 1 does not provide user instruction for responding to such an event.

Device

ADVANCED PERFUSION SYSTEM 1 - BASE UNIT
  • Modèle / numéro de série
    Model Catalog: 801763 (Lot serial: 0020); Model Catalog: 801763 (Lot serial: 0021); Model Catalog: 801763 (Lot serial: 0017); Model Catalog: 801763 (Lot serial: 0013); Model Catalog: 801763 (Lot serial: 1412); Model Catalog: 801763 (Lot serial: 0142); Model Catalog: 801763 (Lot serial: 0144); Model Catalog: 801763 (Lot serial: 0146); Model Catalog: 801763 (Lot serial: 0170); Model Catalog: 801763 (Lot serial: 0193); Model Catalog: 801763 (Lot serial: 0396); Model Catalog: 801763 (Lot serial: 1177); Model Catalog: 801763 (Lot serial: 1312); Model Catalog: 801763 (Lot serial: 1340); Model Catalog: 801763 (Lot serial: 1360); Model Catalog: 801763 (Lot serial: 1361); Model Catalog: 801763 (Lot serial: 1367); Model Catalog: 801763 (Lot serial: 1374); Model Catalog: 801763 (Lot serial: 1411)
  • Description du dispositif
    BASE FOR TERUMO ADVANCED PERFUSION SYSTEM 1
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.