Events

Notificaciones De Seguridad De Campo acerca de FUJIFILM Digital Mammography System AMULET f/s(FDR MS-2500/2000), AMULET Innovality(FDR MS-3500)

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por FUJIFILM.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    There was a case that the swivel arm went down unintentionally when it was moved up/down. based on the investigation result, it has been determined that the possibility of occurrence in other devices is very low. however, in order to further enhance the safety, improvement is made as a voluntary field correction to prevent the swivel arm from going down unintentionally in all the devices having the same structure. while the probability that a problem occurs is very rare; fujifilm wishes to reduce any potential risk to patients as soon as possible.

Device

FUJIFILM Digital Mammography System AMULET f/s(FDR MS-2500/2000), AMULET Innovality(FDR MS-3500)

Manufacturer

FUJIFILM