Events

Rappel de MODEL 860 TRANSCUTANEOUS CO2/O2 MONITOR SYSTEM - MONITOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par RESPIRONICS CALIFORNIA LLC.

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
    66207
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-12-11
  • 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
    Certain types of electri-cord manufacturing company power cords used with medical devices may be defective as the power cords prongs may crack and fail at or inside the plug. the issue affects medical device ac power cords equipped with a plug that has a prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug ("tall bridge" design). medical device power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected.

Device

MODEL 860 TRANSCUTANEOUS CO2/O2 MONITOR SYSTEM - MONITOR
  • Modèle / numéro de série
    Model Catalog: U6590-00 (Lot serial: 1432); Model Catalog: 6590-00 (Lot serial: 1432); Model Catalog: U6590-00 (Lot serial: 1392); Model Catalog: 6590-00 (Lot serial: 1392); Model Catalog: U6590-00 (Lot serial: 1594); Model Catalog: 6590-00 (Lot serial: 1594); Model Catalog: 5758-00 (Lot serial: 5904); Model Catalog: 5758-00 (Lot serial: 4824); Model Catalog: 5758-00 (Lot serial: 5629); Model Catalog: 5758-00 (Lot serial: 4859); Model Catalog: 5758-00 (Lot serial: 4728); Model Catalog: 5758-00 (Lot serial: 4723); Model Catalog: 5758-00 (Lot serial: 6213); Model Catalog: 5758-00 (Lot serial: 5436); Model Catalog: U6590-00 (Lot serial: 1579); Model Catalog: 6590-00 (Lot serial: 1579); Model Catalog: U6590-00 (Lot serial: 2129); Model Catalog: 6590-00 (Lot serial: 2129); Model Catalog: U6590-00 (Lot serial: 1509); Model Catalog: 6590-00 (Lot serial: 1509); Model Catalog: U6590-00 (Lot serial: 1472); Model Catalog: 6590-00 (Lot serial: 1472); Model Catalog: U6590-00 (Lot serial: 1455); Model Catalog: 6590-00 (Lo
  • Description du dispositif
    MODEL 860 TRANSCUTANEOUS CO2/O2 MONITOR SYSTEM
  • Manufacturer
    RESPIRONICS CALIFORNIA LLC

Manufacturer

RESPIRONICS CALIFORNIA LLC
  • Adresse du fabricant
    CARLSBAD
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC