Events

Alerta De Seguridad para NucliSENS easyMAG Software

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

¿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
    2015-11-03
  • Fecha de publicación del evento
    2015-11-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151103c.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: biomerieux nuclisens easymag software medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its nuclisens easymag software [catalogue number: 280106; software version: 2.0]. the manufacturer has identified some anomalies in the affected devices operating on windows xp with easymag software version 2.0. according to the manufacturer, evaluation of the associated anomalies indicates there is no potential for erroneous test results. the manufacturer is implementing a software update, nuclisens easymag software version 2.1, which will resolve the anomalies. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 november 2015.

Device

NucliSENS easyMAG Software
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: bioMerieux NucliSENS easyMAG Software
  • Manufacturer
    bioMerieux

Manufacturer

bioMerieux