Events

Rappel de VITAL SIGNS 300 SERIES NIBP MONITOR AND NELLCOR SPO2

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par WELCH ALLYN CANADA LIMITED.

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
    30596
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-12-04
  • 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 firm distributed a field correction letter notifying users to check that the audio function is working each time they use the device with a label for each unit and new updated dfus.

Device

VITAL SIGNS 300 SERIES NIBP MONITOR AND NELLCOR SPO2
  • Modèle / numéro de série
    Model Catalog: 53S00-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N00-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N00-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N0P-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53S0P-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53S0P-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53S00-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N0P-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530TP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530TP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1R (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-F1 (Lot serial:
  • Description du dispositif
    VITAL SIGNS 300 MONITOR/NELLCOR SPO2
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED