Events

Rappel de APEXPRO TELEMETRY SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    119416
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-08-26
  • 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
    Potential loss of patient monitoring when apexpro telemetry system is used with a "mirrowed" view carescape cic pro in combination monitoring mode which may result in delay of treatment of a cardiac event.

Device

APEXPRO TELEMETRY SYSTEM
  • Modèle / numéro de série
    Model Catalog: APROT1-XX-XXX-XXX-X (Lot serial: S/N'S A1GQ0243G B1GQ0333G); Model Catalog: APROT1-XX-XXX-XXX-X (Lot serial: M0GQ0133G M0GQ0139G); Model Catalog: APROT1-XX-XXX-XXX-X (Lot serial: C1GQ0377G F1GQ0696G); Model Catalog: CIC3APRO=XXX (Lot serial: L34T4067G); Model Catalog: CICV4APRO=X (Lot serial: L34T4067G); Model Catalog: CICV4APRO=X (Lot serial: S/N'S AA104220209GA); Model Catalog: CICV4APRO=X (Lot serial: AA104260532GA D34T2533G); Model Catalog: CIC3APRO=XXX (Lot serial: S/N'S AA104220209GA); Model Catalog: CIC3APRO=XXX (Lot serial: AA104260532GA D34T2533G); Model Catalog: CARESCAPE TELEMETRY SERVER (Lot serial: MANUFACTURER); Model Catalog: APRSRVR16=XXX (Lot serial: >10 NUMBERS); Model Catalog: CARESCAPE TELEMETRY SERVER (Lot serial: >10 NUMBERS); Model Catalog: APRSRVR16=XXX (Lot serial: CONTACT); Model Catalog: CARESCAPE TELEMETRY SERVER (Lot serial: CONTACT); Model Catalog: APRSRVR16=XXX (Lot serial: MANUFACTURER)
  • Description du dispositif
    APEXPRO TELEMETRY SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)