Events

Alerta De Seguridad para acuson sc2000 ultrasound 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
    2014-01-07
  • Fecha de publicación del evento
    2014-01-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140107a.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: siemens acuson sc2000 ultrasound systems the australia therapeutic goods administration (tga) posted a medical device safety alert concerning acuson sc2000 ultrasound systems manufactured by siemens ltd. according to the manufacturer, the user interface module on the ultrasound system consists of the console (monitor, control panel and keyboard) and the swivel mechanism.The swivel mechanism is used for adjusting the height and rotation of the console and is attached to the column on the ultrasound system. if the connection of the user interface module to the column on the ultrasound system is loose, the entire module may fall off the ultrasound system resulting in injuries. the manufacturer advises end users to inspect their units for any looseness in the attachment of the interface module to the column on the ultrasound system. if looseness is observed, the user should discontinue use of the device immediately and contact the manufacturer. a service engineer will perform the necessary repairs. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00005-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 january2014.

Device

acuson sc2000 ultrasound systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Siemens ACUSON SC2000 Ultrasound Systems
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd