Events

Alerta De Seguridad para NobelClinician Software

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

¿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
    2012-07-13
  • Fecha de publicación del evento
    2012-07-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120713.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: nobel biocare nobelclinician software medical device manufacturer, nobel biocare issued a medical device safety alert concerning nobelclinician software version 1.1-1.3. nobel biocare has received a complaint on the surgical template not matching the planning software regarding sleeve diameter. after investigation, it was discovered that a bug is causing the mismatch. the event concerns when a size nobelactive rp implant is planned to be used and the implant diameter is changed. if the change is not done through the conventional ‘product selection dialog', the sleeve in the surgical template will not update and will correspond to the size of the originally selected implant. the resulting surgical template will have sleeves that can be too small or too big for the instruments. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 july 2012.

Device

NobelClinician Software
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Nobel Biocare NobelClinician Software
  • Manufacturer
    Nobel Biocare

Manufacturer

Nobel Biocare