Events

Rappel de MULTI-PARAMETER MODULE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SPACELABS HEALTHCARE 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
    41861
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2001-10-18
  • 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
    There is an anomaly in the ecg software that fails to detect low heart rates in the range of 12 to 15 bpm under some unusual conditions. only one report has been received regarding this anomaly.

Device

MULTI-PARAMETER MODULE
  • Modèle / numéro de série
    Model Catalog: 90470 (Lot serial: CONTACT); Model Catalog: 90470 (Lot serial: >1000 NUMBERS); Model Catalog: 90470 (Lot serial: MANUFACTURER); Model Catalog: 90344 (Lot serial: MANUFACTURER); Model Catalog: 90496 (Lot serial: CONTACT); Model Catalog: 90478 (Lot serial: MANUFACTURER); Model Catalog: 90478 (Lot serial: CONTACT); Model Catalog: 90478 (Lot serial: >100 NUMBERS); Model Catalog: 90348 (Lot serial: MANUFACTURER); Model Catalog: 90346 (Lot serial: MANUFACTURER); Model Catalog: 90496 (Lot serial: >1000 NUMBERS); Model Catalog: 90342 (Lot serial: MANUFACTURER); Model Catalog: 90348 (Lot serial: CONTACT); Model Catalog: 90346 (Lot serial: CONTACT); Model Catalog: 90344 (Lot serial: CONTACT); Model Catalog: 90342 (Lot serial: CONTACT); Model Catalog: 90348 (Lot serial: >10 NUMBERS); Model Catalog: 90346 (Lot serial: >10 NUMBERS); Model Catalog: 90344 (Lot serial: >10 NUMBERS); Model Catalog: 90342 (Lot serial: >10 NUMBERS); Model Catalog: 90496 (Lot serial: MANUFACTURER)
  • Description du dispositif
    90470 MULTI-PARAMETER MODULE
  • Manufacturer
    SPACELABS HEALTHCARE INC.

Manufacturer

SPACELABS HEALTHCARE INC.
  • Adresse du fabricant
    SNOQUALMIE
  • Source
    HC