Events

Rappel de REUSABLE HANDPIECES

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CYNOSURE INC. DBA ELLMAN.

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
    15363
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-24
  • 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
    Failure of the d110fshp and d115fshp reusable handpieces. the wires in the cord may break. if the handpiece is used after the wires break it may spark and the cord may detach from the handpiece.

Device

REUSABLE HANDPIECES
  • Modèle / numéro de série
    Model Catalog: D115FSHP (Lot serial: 63595); Model Catalog: D110FSHP (Lot serial: 63595); Model Catalog: D115FSHP (Lot serial: 36374); Model Catalog: D110FSHP (Lot serial: 36374); Model Catalog: D115FSHP (Lot serial: 36209); Model Catalog: D110FSHP (Lot serial: 36209); Model Catalog: D115FSHP (Lot serial: 35969); Model Catalog: D110FSHP (Lot serial: 35969); Model Catalog: D115FSHP (Lot serial: 35181); Model Catalog: D110FSHP (Lot serial: 35181); Model Catalog: D115FSHP (Lot serial: 31522); Model Catalog: D110FSHP (Lot serial: 31522); Model Catalog: D115FSHP (Lot serial: 29788); Model Catalog: D110FSHP (Lot serial: 29788); Model Catalog: D115FSHP (Lot serial: 36594); Model Catalog: D110FSHP (Lot serial: 36594); Model Catalog: D115FSHP (Lot serial: 36314); Model Catalog: D110FSHP (Lot serial: 36314); Model Catalog: D115FSHP (Lot serial: 35989); Model Catalog: D110FSHP (Lot serial: 35989); Model Catalog: D115FSHP (Lot serial: 35559); Model Catalog: D110FSHP (Lot serial: 35559); Model Catalog: D115FSHP (Lot seri
  • Description du dispositif
    D110FSHP and D115FSHP REUSABLE HANDPIECES
  • Manufacturer
    CYNOSURE INC. DBA ELLMAN

Manufacturer

CYNOSURE INC. DBA ELLMAN
  • Adresse du fabricant
    HICKSVILLE
  • Société-mère du fabricant (2017)
    Hologic, Inc.
  • Source
    HC