Events

Alerta De Seguridad para 560P High Definition Camera Control Unit

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

¿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
    2012-03-30
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120330.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
    Field safety notice: smith & nephew 560p high definition camera control unit medical device manufacturer, smith & nephew inc., issued a field safety notice concerning certain 560p high definition camera control unit [product code: 72201919; serial no.: bbs1203 & bbs1450]. user of the device may experience intermittent loss of video due to a defective board component, which was incorporated during the manufacturing process. according to the manufacturer, there is a risk of inadvertent damage to non-target tissue while visualization is not functioning correctly if loss of video or display is experienced during the surgical procedure. according to the local supplier, the affected devices were distributed to hong kong. for more details, please refer to the attachment. if you are in possession of the product, please contact your supplier for necessary actions.

Device

560P High Definition Camera Control Unit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Smith & Nephew 560P High Definition Camera Control Unit
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew