Events

Alerta De Seguridad para brightview xct

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Philips 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
    2013-09-09
  • Fecha de publicación del evento
    2013-09-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130909.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: philips brightview xct the therapeutic goods administration (tga), australia posted a medical device safety alert concerning brightview xct manufactured by philips healthcare (model numbers 882482 and 882454). philips received a report from the field that the flat panel detector (fpd) sensor reported to the operator that the panel was unlatched at the zero degree position during setup. the operator attempted to manually relatch the fpd as it remained in the zero degree position. in trying to restow the fpd, it fell from its stowed position and contacted the patient's leg and the technologist's arm. the manufacturer advises customer to keep the fpd in the deployed position until the implementation of the appropriate field safety correction. for details, please refer to tga website http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00944-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 9 september 2013.

Device

brightview xct
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips BrightView XCT
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH