Events

Rappel de PRECISION MPI 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
    26495
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-06-16
  • 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
    Ge healthcare has recently become aware of a reported incident of a monitor that fell from the suspension. a fall of a monitor could result in an injury to a patient or operator.There have been no injuries reported as a result of this issue.

Device

PRECISION MPI SYSTEM
  • Modèle / numéro de série
    Model Catalog: S0800SA/SC/SB/SD (Lot serial: 1406MC8); Model Catalog: S0800SA/SC/SB/SD (Lot serial: 1275MC7); Model Catalog: S0800SA/SC/SB/SD (Lot serial: 1057MC9); Model Catalog: S0800SA/SC/SB/SD (Lot serial: 1420MC9); Model Catalog: S0800SA/SC/SB/SD (Lot serial: 1055MC3); Model Catalog: S0800SA/SC/SB/SD (Lot serial: 3511MC3); Model Catalog: S0800SA/SC/SB/SD (Lot serial: 1430MC8); Model Catalog: S0915KE (Lot serial: 0948MC0); Model Catalog: S0915KE (Lot serial: 1122MC1); Model Catalog: S0915KE (Lot serial: 4013MC9); Model Catalog: S0915KE (Lot serial: 1506MC5); Model Catalog: PRECISION RXI 5117828 (Lot serial: 1407MC6); Model Catalog: PRECISION RXI 5117828 (Lot serial: 1388MC8); Model Catalog: PRECISION RXI 5117828 (Lot serial: 1381MC3); Model Catalog: PRECISION RXI 5117828 (Lot serial: 1296MC3); Model Catalog: PRECISION RXI 5117828 (Lot serial: 1652MC7); Model Catalog: PRECISION RXI 5117828 (Lot serial: 1453MC0); Model Catalog: PRECISION RXI 5117828 (Lot serial: 1020MC7); Model Catalog: PRECISION RXI 51178
  • Description du dispositif
    PRECISION MPI SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)