Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por GE Healthcare.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 099 11 18 000
  • Fecha de inicio del evento
    2018-11-28
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13548
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. information to assist you in identifying whether you have an impacted software version is provided in this communication. if the incorrect software version is loaded on the brivo mr355, optima 360, signa profile, signa ovation hd, signa ovation .35t, signa hfo, signa hde, signa ovation with excite, 0.7t signa openspeed, signa infinity with excite technology, signa excite 3t and 1.5t signa hdxt systems the images can be flipped left/right and/or there can be patient data mismatch.

Device

Multiple GE MRI systems
  • Modelo / Serial
    This correction applies to some units of the following GE Healthcare MRI system types: Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity & Signa Infinity Twinspeed, Signa Profile, Signa Ovation .35T, Signa HFO, Signa Ovation with Excite & 0.7T Signa OpenSpeed, Signa Ovation HD, Signa HDe, 1.5T Signa HDxt, Brivo MR355 & Optima MR360, Signa Creator & Signa Explorer.
  • Descripción del producto
    MRI systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare