Events

Rappel de IVEA MODEL 500A

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CANADIAN HOSPITAL SPECIALTIES LTD..

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
    79358
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-10-11
  • 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
    Rotational forces on the 16082 dowel pin during deploying or folding can cause the pin to slowly "screw" its way out of position. if the pin migrates enough to allow the brace to detach from the leg pivot fitting while a patient is ambulating with weight on the handles the product could slump to one side. this may cause the patient to stumble .

Device

IVEA MODEL 500A
  • Modèle / numéro de série
    Model Catalog: 500A (Lot serial: 100677); Model Catalog: 500A (Lot serial: 100650); Model Catalog: 500A (Lot serial: 100325); Model Catalog: 500A (Lot serial: 100463); Model Catalog: 500A (Lot serial: 100476); Model Catalog: 500A (Lot serial: 100647); Model Catalog: 500A (Lot serial: 100646); Model Catalog: 500A (Lot serial: 100645); Model Catalog: 500A (Lot serial: 100643); Model Catalog: 500A (Lot serial: 100642); Model Catalog: 500A (Lot serial: 100641); Model Catalog: 500A (Lot serial: 100640); Model Catalog: 500A (Lot serial: 100627); Model Catalog: 500A (Lot serial: 100626); Model Catalog: 500A (Lot serial: 100620); Model Catalog: 500A (Lot serial: 100615); Model Catalog: 500A (Lot serial: 100605); Model Catalog: 500A (Lot serial: 100602); Model Catalog: 500A (Lot serial: 100600); Model Catalog: 500A (Lot serial: 100598); Model Catalog: 500A (Lot serial: 100592); Model Catalog: 500A (Lot serial: 100574); Model Catalog: 500A (Lot serial: 100572); Model Catalog: 500A (Lot serial: 100571); Model Catalog:
  • Description du dispositif
    IVEA MODEL 500A
  • Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LTD.

Manufacturer

CANADIAN HOSPITAL SPECIALTIES LTD.