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
    85356
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-09-14
  • 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 advanced perfusion system 1 battery charge is being depleted faster than expected during periods of system shutdown. the system 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use such as would occur with a backup system. this may result in unexpected system shutdown. prolonged battery depletion may cause permanent battery damage.

Device

ADVANCED PERFUSION SYSTEM 1 - BASE UNIT
  • Modèle / numéro de série
    Model Catalog: 801763 (Lot serial: 1109-1445); Model Catalog: 801763 (Lot serial: 1412); Model Catalog: 801763 (Lot serial: 1100); Model Catalog: 801763 (Lot serial: 1037-1049); Model Catalog: 801763 (Lot serial: 1001-1034); Model Catalog: 801763 (Lot serial: 0337-0610); Model Catalog: 801763 (Lot serial: 0011-0335); Model Catalog: 801763 (Lot serial: 1447-1450); Model Catalog: 801763 (Lot serial: 0013); Model Catalog: 801763 (Lot serial: 0017); Model Catalog: 801763 (Lot serial: 0020); Model Catalog: 801763 (Lot serial: 0021); 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
  • Description du dispositif
    TERUMO ADVANCED PERFUSION SYSTEM 1 - BASE UNIT (100/120V)
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.