Rappel de STANDARD SLINGBAR 450

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par HILL-ROM CANADA 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
    83019
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-04-09
  • Pays de l'événement
  • 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
    There have been 6 complaints of injury related to the product over the past 32 years (6 out of 838687856 estimated patient uses). one of the injuries was associated with a patient during use four injuries occurred when the slingbar was not in use where someone tripped and fell onto the unit and one where a child was playing on a lift and was injured when they tried to jump from the lift.

Device

  • Modèle / numéro de série
    Model Catalog: N/A (Lot serial: 3156007); Model Catalog: N/A (Lot serial: 20090029); Model Catalog: N/A (Lot serial: 20190024); Model Catalog: N/A (Lot serial: 20190041); Model Catalog: N/A (Lot serial: 31190015); Model Catalog: N/A (Lot serial: 31290017); Model Catalog: N/A (Lot serial: 31290043); Model Catalog: N/A (Lot serial: 3156001); Model Catalog: N/A (Lot serial: 3156003); Model Catalog: N/A (Lot serial: 3156014); Model Catalog: N/A (Lot serial: 3156016); Model Catalog: N/A (Lot serial: 31590043); Model Catalog: N/A (Lot serial: 5019013)
  • Description du dispositif
    STANDARD SLINGBAR 450
  • Manufacturer

Manufacturer