Events

Alerta De Seguridad para portable dental x-ray units

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Zhengzhou Tianjie Electronic Equipment Co.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-07-17
  • Fecha de publicación del evento
    2012-07-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120717.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: portable dental x-ray units the medicines and healthcare products regulatory agency (mhra) of the united kingdom has issued a medical device alert concerning non ce-marked portable dental x-ray units including the tianjie dental falcon, manufactured by zhengzhou tianjie electronic equipment co. according to the mhra, 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. in addition, the tianjie dental falcon portable x-ray unit is not ce-marked as a medical device and could be purchased on ebay. it is identical in appearance to a number of other non ce-marked devices that are available on the internet. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts/ index.Htm posted on 17 july 2012.

Device

portable dental x-ray units

Manufacturer

Zhengzhou Tianjie Electronic Equipment Co
  • Source
    DH