Events

Alerta De Seguridad O Notificaciones De Seguridad para Non CE-marked portable 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 Zhengzhou Tianjie Electronic Equipment Co.

¿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
  • ID del evento
    MDA/2012/046
  • Número del evento
    CON173752
  • Fecha
    2012-07-16
  • Fecha de publicación del evento
    2012-07-16
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON173752?tabName=allTabs
  • 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
  • Causa
    Testing by the health protection agency (hpa) has revealed that the tianjie dental falcon device lacks sufficient shielding in the x-ray tube, which could give rise to high patient doses and under typical high radiographic workloads result in operator doses in excess of the ionising radiation regulations 1999 annual dose limits. this could give rise to adverse health effects caused by radiation. the tianjie dental falcon is not ce-marked as a medical device.
  • Acción
    Identify and stop using this and similar non CE-marked devices. Replace the device with a suitable CE-marked alternative. Be aware of the NRPB (HPA) Guidance Notes for Dental Practitioners on the Safe Use of X-Ray Equipment or the Medical & Dental Guidance Notes published by IPEM. Be aware of the general requirement to consult a suitable radiation protection adviser with regard to the use of X-ray equipment. Be aware of MHRA advice on the use of non-CE marked devices. Report any suspected devices to MHRA Adverse Incident Centre.

Device

Non CE-marked portable dental X-ray units
  • Modelo / Serial
  • Descripción del producto
    Non CE-marked portable dental X-ray units. Including the Tianjie Dental ‘Falcon’. The Tianjie Dental Falcon portable X-ray unit is not CE-marked as a medical device and was purchased on eBay. It is identical in appearance to a number of other non CE-marked devices that are available on the internet:
  • Manufacturer
    Zhengzhou Tianjie Electronic Equipment Co

Manufacturer

Zhengzhou Tianjie Electronic Equipment Co
  • Source
    MHRA