Events

Rappel de Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCRECAll units serviced with Field Replaceable Unit catalogue number M1013204 between February 2012 and May 2014.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia Pty Ltd.

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
    RC-2014-RN-00620-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-06-06
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00620-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Ge healthcare has become aware of a potential safety issue due to failure of the carbon dioxide detector associated with single-width airway and extension modules. failure of the carbon dioxide detector in single-width airway and extension modules may cause a slow continuous decrease of measured et-/fico2 values. incorrect et co2/fi co2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low co2 values.This action has been undertaken further to the previous recall action (rc-2014-rn-00543-1) since ge has identified that all units serviced with field replaceable unit catalogue number m1013204 between february 2012 and may 2014 are affected by this issue.
  • Action
    GE is providing calibration instructions to assist their customers to determine if their module is affected. If the carbon dioxide reading is out of range after the first successful calibration procedure end users are advised to discontinue use and contact a GE service representative. This action has been closed-out on 02/02/2016.

Device

Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCRECAll units serviced with Fi...
  • Modèle / numéro de série
    Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCRECAll units serviced with Field Replaceable Unit catalogue number M1013204 between February 2012 and May 2014.ARTG Number: 166230
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd