Events

Rappel de GE LOGIQ S8 and LOQIQ S7 Ultrasound

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par GE Ultrasound Korea 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
    14572
  • Date de mise en oeuvre de l'événement
    2013-04-30
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    Manufacturer has recently become aware of a potential safety issue due to the s4-10-d ultrasound probe used in conjunction with the logiq s8 and logiq s7 ultrasound systems. it was also discovered that this issue also leads to a specification issue of the acoustic output of this probe, there is a potential for a skin burn when the flow model in the cardiac application is activated with the s4-10-d ultrasound probe.
  • Action
    Software to be upgraded

Device

GE LOGIQ S8 and LOQIQ S7 Ultrasound
  • Modèle / numéro de série
    Model: , Affected: with software revisions R.1.1.1 , R1.5.1 and R1.0.1, R1.0.2 and R1.0.3
  • Manufacturer
    GE Ultrasound Korea Ltd

Manufacturer

GE Ultrasound Korea Ltd