Events

Alerta De Seguridad para neuro / inspire - surgical planning software

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

¿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
    2014-11-11
  • Fecha de publicación del evento
    2014-11-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141111.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: renishaw neuro / inspire - surgical planning software the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning neuro / inspire - surgical planning software (product code: a-5630-3000-a6 and a-5630-3001-a4; software version: 4.0.1665.3; lot numbers: all), manufactured by renishaw. the manufacturer’s internal processes have discovered a bug in neuro inspire v4.0.1665.3 that could potentially result in the software getting into an indeterminate state under certain circumstances. if neuro inspire gets into this state, it may affect surgical planning activities and/or the quality of data produced as an output. this bug may result in a delay to the surgical procedure which in turn may extend the application of general anaesthetic, and risk of infection may also be raised on this basis. the bug may lead to a targeting error that could potentially result in permanent long term injury or life threatening injury to the patient. users should not use the affected products for any clinical procedure until further notice. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con471136 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 november 2014.

Device

neuro / inspire - surgical planning software
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Renishaw neuro / inspire - surgical planning software
  • Manufacturer
    Renishaw

Manufacturer

Renishaw