Events

Alerta De Seguridad para Sonopet Console

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

¿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
    2013-06-10
  • Fecha de publicación del evento
    2013-06-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130610.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: stryker sonopet console the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning sonopet console, manufactured by stryker. the affected catalogue number is 5450852000 and the affected serial numbers are 1134000114, 1134000124, 1134000134, 1134000144, 1134000184, 1134000204 & 1209400174. according to the tga, the manufacturer has received reports that the irrigation pump may not function and audible alarm may not sound. in case where the irrigation pump fails, saline would not be provided to the tip. the manufacturer will be replacing affected units with a loan unit until the unit is repaired. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00578-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 jun 2013.

Device

Sonopet Console
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Stryker Sonopet Console
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH