Alerta De Seguridad para e.cam and symbia e systems

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

¿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
    2013-11-04
  • Fecha de publicación del evento
    2013-11-04
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: siemens e.Cam and symbia e systems the therapeutic goods administration (tga), australia has issued a medical device safety alert concerning e.Cam and symbia e systems [siemens reference number: mi017/13/s; serial number: all], manufactured by siemens ltd. the manufacturer has received reports of loose bolts on system detectors for symbia e and e.Cam, which secure the detectors to the yoke. the manufacturer is advising users that all affected units will be inspected for loose screws and corrected if required. affected units can continue to be used. for details, please visit the following mhra website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01118-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 november 2013.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Siemens E.cam and Symbia E systems
  • Manufacturer

Manufacturer