Events

Rappel de PENTAX VB-2000 VIDEO BRONCHOSCOPE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PENTAX 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
    98635
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-07-10
  • 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
    Pentax medical has become aware that some customers may own legacy endoscopes where the screw connecting the suction arm to the control body could loosen with time. a loose suction arm may result in inadequate suctioning due to leakage of air. there is also the potential for organic debris to accumulate in the space between the suction nipple and control body. in some cases these events could cause cross-contamination between patients.

Device

PENTAX VB-2000 VIDEO BRONCHOSCOPE
  • Modèle / numéro de série
    Model Catalog: EB-1970TK (Lot serial: G111020); Model Catalog: EB-117OK (Lot serial: G110123); Model Catalog: EB-1970K (Lot serial: G110123); Model Catalog: EB-1970TK (Lot serial: G110123); Model Catalog: EB-117OK (Lot serial: G110458); Model Catalog: EB-1570K (Lot serial: G110458); Model Catalog: EB-1970K (Lot serial: G110458); Model Catalog: EB-1970TK (Lot serial: G110458); Model Catalog: EB-117OK (Lot serial: G110907); Model Catalog: EB-1570K (Lot serial: G110907); Model Catalog: EB-1970K (Lot serial: G110907); Model Catalog: EB-1970TK (Lot serial: G110907); Model Catalog: EB-117OK (Lot serial: G110589); Model Catalog: EB-1570K (Lot serial: G110589); Model Catalog: EB-1970K (Lot serial: G110589); Model Catalog: EB-1970TK (Lot serial: G110589); Model Catalog: EB-117OK (Lot serial: G110017); Model Catalog: EB-1570K (Lot serial: G110017); Model Catalog: EB-1970K (Lot serial: G110017); Model Catalog: EB-1970TK (Lot serial: G110017); Model Catalog: EB-117OK (Lot serial: G110029); Model Catalog: EB-1570K (Lot s
  • Description du dispositif
    PENTAX VB-2000 VIDEO BRONCHOSCOPE;E.N.T. SCOPE;SLIM CYSTOSCOPE SET
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

PENTAX CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    HC