Events

Alerte De Sécurité sur ViewPoint 6

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par GE Healthcare.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-08-05
  • Date de publication de l'événement
    2013-08-05
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130805a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: ge healthcare viewpoint 6 the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning viewpoint 6 versions 6.2, 6.2.1, 6.3 and 6.31 including ob pro-expert reporting (ultrasound image management software) manufactured by ge healthcare. ge healthcare has become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (piv) for venous flow measurements. the ductus venous piv measurement can be incorporated into the first trimester risk assessment for chromosomal abnormalities. in case of negative flow patterns, the viewpoint calculated doppler piv for veins could be incorrect, leading to a false high risk for trisomy 13, 18, and 21. ge healthcare is advising users to discontinue use of venous piv for making any clinical decisions, in particular, discontinue use of the ductus venous piv for first trimester risk assessment. in addition, ge healthcare will be providing a software upgrade as a permanent fix. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00812-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 august 2013.

Device

ViewPoint 6
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare ViewPoint 6
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare