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 092 10 11 000
  • Fecha de inicio del evento
    2011-10-30
  • 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=971
  • 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
    Ge healthcare has become aware of an issue associated with the base casting for the articulated arm of the vmx and vmx plus mobile x-ray systems that may impact operator or patient safety. the casting which retains the articulated arm to the base of the vmx may develop fatigue cracks through long term use of the product. if the casting develops cracks of significant size, the articulated arm may no longer be properly secured to the base of the vmx. the loss of retention may permit the articulated arm, x-ray tube, and collimator to fall in an uncontrolled manner. the fall of this object may create a hazard to operators and patients during transport or use of the equipment.

Device

Diagnostic, general-purpose, MobileX-ray system
  • Modelo / Serial
    VMX and VMX Plus
  • Descripción del producto
    X-ray system, diagnostic, general-purpose, mobile
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare