Events

Rappel de INFANT RADIANT WARMERS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par FISHER AND PAYKEL HEALTHCARE 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
    19328
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2014-11-03
  • 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
    Fisher & paykel healthcare is issuing this voluntary recall notice because it has had two confirmed reports of breakage of the nut that secures the heater head in place. breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. the heater head did not contact the patient in either case. however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.

Device

INFANT RADIANT WARMERS
  • Modèle / numéro de série
    Model Catalog: IW952 (Lot serial: 071208002349 TO 090717000930); Model Catalog: IW980 (Lot serial: 071208002349 TO 090717000930); Model Catalog: IW920 (Lot serial: 071208002349 TO 090717000930); Model Catalog: IW910 (Lot serial: 071208002349 TO 090717000930); Model Catalog: 648040142 (Lot serial: 071116 TO 090810); Model Catalog: 043042359 (Lot serial: 071116 TO 090810); Model Catalog: 043041130 (Lot serial: 071116 TO 090810); Model Catalog: IW954 (Lot serial: 071116 TO 090810); Model Catalog: IW953 (Lot serial: 071116 TO 090810); Model Catalog: IW951 (Lot serial: 071116 TO 090810); Model Catalog: IW990 (Lot serial: 071116 TO 090810); Model Catalog: IW934 (Lot serial: 071116 TO 090810); Model Catalog: IW933 (Lot serial: 071116 TO 090810); Model Catalog: IW932 (Lot serial: 071116 TO 090810); Model Catalog: IW931 (Lot serial: 071116 TO 090810); Model Catalog: IW952 (Lot serial: 071116 TO 090810); Model Catalog: IW980 (Lot serial: 071116 TO 090810); Model Catalog: IW920 (Lot serial: 071116 TO 090810); Model Cat
  • Description du dispositif
    INFANT RADIANT WARMERS
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.