Alerta De Seguridad O Notificaciones De Seguridad para UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems

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 MECALL Srl.

¿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
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The MHRA has received a report of the X-ray tube head falling onto the table after the support cable and the backup ‘safety device’ failed simultaneously. The tube head weighs 40 kg and there is a risk of death or serious patient injury if this failure occurs during examination.The X-ray tube head is supported by a metal rope that winds over a pulley system behind the tube support covers. There is a safety device fitted, which should catch the rope if it breaks.Wear on the cable may go undetected as the current service instructions for this device do not require that the whole length of the cable is inspected nor do they require that the ‘safety device’ is inspected.The manufacturer has updated the service instructions and issued a Field Safety Notice, available to download from:X-ray, ancillary equipment and accessories - Mecall Srl - UNISTAT L floor stand.
  • Causa
    (mecall srl) an x-ray tube head has fallen onto the table after the support cable and the backup ‘safety device’ failed at the same time. (mda/2009/014).
  • Acción
    Identify any affected devices. Immediately remove from service. Contact the manufacturer. Ensure that the whole length of the support cable and the ‘safety device’ are inspected following the updated service instructions and are free from defect before returning into service.


  • Modelo / Serial
  • Descripción del producto
    UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems.These stands were manufactured between 1990 and 2000.See attachment for suppliers, serial numbers and location of serial number label.
  • Manufacturer


  • Dirección del fabricante
    ManufacturerLuigi Besana Safety and Regulatory Manager MECALL S.r.l. Via Negrelli 55 20035 Lissone (Mi) Italy Tel: +39 039 243 1525 Fax: +39 039 464 819Email:
  • Source