Events

Rappel de DASH 4000 PATIENT MONITOR

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
    106164
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-01-18
  • 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
    Ge healthcare became aware of the following issues affecting dash 3000/4000/5000 patient monitors and dash port 2. dash 3000/4000/5000 patient monitors: 1. dash stops communicating on the unity network resulting in loss of monitoring at the carescapet cic pro central station* 2. dash displays distorted ecg waveforms in combination monitoring mode 3. dash incorrectly becomes time master on the unity network 4. dash date reverts to 1993 dash port 2: 5. dash port 2 stops communicating on the unity network resulting in loss of monitoring at the carescapet cic pro central station* *despite communication loss the dash 3000/4000/5000 will continue to provide bedside monitoring including alarms and event storage.

Device

DASH 4000 PATIENT MONITOR
  • Modèle / numéro de série
    Model Catalog: DASH4-XXXX-XXXX-XXXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: DASH5-XXXX-XXXX-XXXX (Lot serial: >10 lot numbers contact mfg); Model Catalog: 2041850-002 (Lot serial: >10 lot numbers contact mfg); Model Catalog: DASH3-XXXX-XXXX-XXXX (Lot serial: > 10 lot numbers contact mfg)
  • Description du dispositif
    DASH 4000 PATIENT MONITOR
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)