Events

Alerta De Seguridad para XR 6000 systems

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
    2016-10-31
  • Fecha de publicación del evento
    2016-10-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161031.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 xr 6000 systems the health sciences authority (hsa) of the singapore has posted a medical device safety alert concerning xr 6000 systems, manufactured by ge healthcare. the manufacturer has recently become aware of a potential safety issue with the horizontal tube arm of the system used on xr 6000 systems. there has been a reported incident of a horizontal tube arm falling from the system. a fall of a tube arm suspending the collimator and tube apparatus could result in a serious injury or death to a patient or operator. a minor injury has been reported as a result of this issue. the manufacturer will correct the affected systems. the manufacturer recommends users not to use the xr 6000 system until they are corrected. for details, please refer to the hsa’s website: http://www.Hsa.Gov.Sg/content/hsa/en/health_products_regulation/medical_devices/product_owners_fsn/2016/september.Html if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 october 2016.

Device

XR 6000 systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Healthcare XR 6000 systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare