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 159 04 18 000
  • Fecha de inicio del evento
    2018-04-30
  • 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=12550
  • 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
    When the gantry front cover is removed to allow servicing of components inside the gantry, cover dollies are used to manipulate the cover. during the removal or reattachment of the front cover, a bracket can contact an internal power supply cable and damage that cable’s insulation. this can expose the conductor of a 120vac power supply cable and electrify the cover dolly, thereby introducing the risk of an electrical shock hazard to the service personnel.

Device

Revolution EVO & Optima CT660, CT670, CT680, CT540 Internal Electrical Cable
  • Modelo / Serial
    The following CT systems are affected: Revolution EVO (Models 5454001-61 GTIN 00840682109796, 5454001-160 GTIN 00840682109796, 5454001-60 GTIN 00840682109796, 5454001-260 GTIN 00840682109796) Optima CT660 (Models 5454001, 5454001-41, -100, -220, -200, -40, -22, -140, -240, -122, -222) Optima CT670/680 (Model 5454001-230, 5454001-330) Optima CT540 (Models 5432539 GTIN 00840682138963, 5432539-2 GTIN 00840682138963, 5432539-3 GTIN 00840682102551, 5432539-5 GTIN 00840682102551, 6447929)
  • Descripción del producto
    X-ray system, diagnostic, computed tomography
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare