Events

Alerta De Seguridad para Discovery 670, Optima 640, Discovery NM630 and Brivo NM615

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por GE Healthcare.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-10-16
  • Fecha de publicación del evento
    2013-10-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016g.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Healthcare Discovery 670, Optima 640, Discovery NM630 and Brivo NM615
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare