Events

Rappel de COMFORTLINE CHAIR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CARDINAL HEALTH 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
    93782
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-03-25
  • 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
    The instructions for use of the therapy chair <>serial number starting from 06c06-018 has been amended to included the following: during installation of the therapy chair the installing staff has to make sure that the seat of the chair is installed correctly and according to the instruction for use. if the seat is not locked properly it might slide unintentionally.

Device

COMFORTLINE CHAIR
  • Modèle / numéro de série
    Model Catalog: 110014 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: LOC-17039 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: 110015 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: 113789 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: 114665 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: NVM-10336 (Lot serial: 06C06-018); Model Catalog: LOC-17119 (Lot serial: 06C06-018); Model Catalog: LOC-17097 (Lot serial: 06C06-018); Model Catalog: LOC-17070 (Lot serial: 06C06-018); Model Catalog: LOC-17039 (Lot serial: 06C06-018); Model Catalog: 114665 (Lot serial: 06C06-018); Model Catalog: 113789 (Lot serial: 06C06-018); Model Catalog: 110015 (Lot serial: 06C06-018); Model Catalog: 109434 (Lot serial: 06C06-018); Model Catalog: 110014 (Lot serial: 06C06-018); Model Catalog: NVM-10336 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: LOC-17119 (Lot serial: SERIAL NUMBERS STARTING FROM); Model Catalog: LOC-17097 (Lot serial: SERIAL NUMBERS STARTING FROM)
  • Description du dispositif
    BIONIC COMFORTLINE CHAIR
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    HC