Events

Alerte De Sécurité sur Discovery 670, Optima 640, Discovery NM630 and Brivo NM615

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
    2013-10-16
  • Date de publication de l'événement
    2013-10-16
  • 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_20131016g.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 discovery 670, optima 640, discovery nm630 and brivo nm615 the therapeutic goods administration (tga), australia issued a medical device safety alert concerning discovery 670, optima 640, discovery nm630 and brivo nm615 (all configurations), manufactured by ge healthcare. contact between the detector and the patient's elbow may occur during single-photon emission computed tomography protocols using 45 degree angular steps in scenarios when a patient's arms are positioned above the head and when dedicated safety armbands are not utilised. ge healthcare advises users to ensure the patient and the patient's extremities are not protruding beyond the table limits. if the patient's arms need to be extended above their head, users are advised to use the armbands provided. a software update will be provided by the manufacturer. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01062-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

Discovery 670, Optima 640, Discovery NM630 and Brivo NM615
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare Discovery 670, Optima 640, Discovery NM630 and Brivo NM615
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare