Events

Rappel de Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits

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-2016-RN-00143-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-02-04
  • 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-2016-RN-00143-1
  • 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 recently become aware of a potential safety issue with the btv switch of certain carestation 600 series anaesthesia systems. the btv switch could become difficult to move between mechanical ventilation and manual bag modes or remain in a position where it is not possible to ventilate the patient using the anaesthesia system. this issue could result in loss of patient ventilation potentially resulting in hypoxia. there have been no customer complaints or injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users that the systems can continued to be used. However users should ensure back up ventilation, independent of the anaesthesia machine is available. GE is advising users all affected devices will be corrected.

Device

Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits
  • Modèle / numéro de série
    Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kitsSerial Numbers: Carestation 620 A1 (GTIN: 00840682103985): SM615020004WA to SM616010008WACarestation 650 A1 (GTIN: 00840682103947): SM715020005WA to SM716010008WACarestation 650c A1 (GTIN: 00840682103954): SM815020001WA to SM815500001WAService kits affected2071003-001-S , BTV SWITCH ASSEMBLY2081000-001-S , ASSY BOTTOM BC2082466-001-S, ASSY BOTTOM BC AUS FEMALE 22ARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd