Alerta De Seguridad para ingenia 1.5t and ingenia 3.0t magnetic resonance systems

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

¿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
    2014-01-30
  • Fecha de publicación del evento
    2014-01-30
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: philips ingenia 1.5t and ingenia 3.0t magnetic resonance systems medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its ingenia 1.5t and ingenia 3.0t magnetic resonance systems [identification numbers: 989603019151, 989603019152, 989603019153, 989603019211, 989603019212 & 989603019213]. according to the manufacturer, under certain conditions, it is possible that the ingenia tabletop gets obstructed and is slowed or halted before it has been fully moved out of the magnet. users may continue to use the system, but in the event that the tabletop becomes blocked, the manufacturer should be contacted for repair. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 january 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Ingenia 1.5T and Ingenia 3.0T Magnetic Resonance systems
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH