Events

Rappel de LIFEDOP 250 SYSTEM - PROBES

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COOPERSURGICAL INC. ALSO TRADING AS WALLACH SURGICAL DEVICES.

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
    17960
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-10-06
  • 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
    The coopersurgical 2 mhz waterproof ob probe is for obstetrical use in the labor and delivery department for late term obstetrical examination associated with larger women. the product detects fetal heart beats as an aid for determining fetal viability. coopersurgical quality assurance program identified that the 2mhz is incorrectly labeled with the 3 mhz probe label on september 19 2017. the event was discovered internally during product complaint investigation.

Device

LIFEDOP 250 SYSTEM - PROBES
  • Modèle / numéro de série
    Model Catalog: SDW (Lot serial: 2017070007); Model Catalog: SDW (Lot serial: 2017070005); Model Catalog: SDW (Lot serial: 2017070009)
  • Description du dispositif
    Summit Doppler 2MHz Waterproof OB Probe
  • Manufacturer
    COOPERSURGICAL INC. ALSO TRADING AS WALLACH SURGICAL DEVICES

Manufacturer

COOPERSURGICAL INC. ALSO TRADING AS WALLACH SURGICAL DEVICES