Events

Alerta De Seguridad para Echostar Spica 1.5T MRI system

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

¿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
    2015-02-27
  • Fecha de publicación del evento
    2015-02-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150227.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: alltech medical systems america echostar spica 1.5t mri system the united states food and drug administration (fda) posted a medical device safety alert concerning echostar spica 1.5t mri system [serial number: d-esp-1001 and d-esp-1003] manufactured by alltech medical systems america. the manufacturer is initiating a voluntary recall as the mri system safety feature, which lowers the magnetic field in emergency situations, may not work correctly. for details, please refer to the following link: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=70238&w=02252015%e2%8c%a9=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 february 2015.

Device

Echostar Spica 1.5T MRI system

Manufacturer

Alltech Medical Systems America