Events

Alerta De Seguridad O Notificaciones De Seguridad para Intra-oral dental X-ray units

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Carestream Health.

¿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
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2014/005
  • Fecha
    2014-02-21
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/medical-device-alert-intra-oral-dental-x-ray-units-kodak-2100-and-kodak-2200-risk-of-injury
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
    Risk of injury if the joint between the scissor arm and bracket fails.This joint could fail prematurely due to a manufacturing problem during the period from May 2008 to April 2010.
  • Causa
    (carestream health) risk of injury if joint between scissor arm and bracket fails. (mda/2014/005).
  • Acción
    Identify affected devices using the guidance in the manufacturer’s Field Safety Notice (195Kb) (FSN). Inspect the units using the pictures in the FSN, to ensure the arm has not failed. If the unit shows signs of failure, stop using it and call your dealer immediately. All systems need to be inspected even if they don’t show signs of failure. Contact your dealer to arrange a service engineer visit.

Device

Intra-oral dental X-ray units
  • Modelo / Serial
  • Descripción del producto
    Intra-oral dental X-ray units: Kodak 2100 and Kodak 2200 (wall and ceiling mounted)Manufactured by Carestream HealthModels released for sale from May 2008 to April 2010, serial numbers as identified in the FSN.
  • Manufacturer
    Carestream Health

Manufacturer

Carestream Health
  • Empresa matriz del fabricante (2017)
    ONEX Corp
  • Source
    MHRA