Events

Rappel de VITAL SIGNS 300 SERIES NIBP MONITOR W/PULSE RATE/MAP AND PRINTER

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
    44082
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-07-09
  • 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
    Speakers in vsm300 vital signs monitor failed to produce sound. the failure of the speaker eliminates audio alarm tones for parameter violation equipment alerts or error codes as well as repetitive beeps to indicate pulses when monitoring sp02 (oximetry).

Device

VITAL SIGNS 300 SERIES NIBP MONITOR W/PULSE RATE/MAP AND PRINTER
  • Modèle / numéro de série
    Model Catalog: 5300P-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530T0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530T0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5300P-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53000-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53000-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1R (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-F1 (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: 530TP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N0P-F1 (Lot serial:
  • Description du dispositif
    VITAL-SIGNS MONITOR W/RATE/MAP PRINTER
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED