Events

Notificaciones De Seguridad De Campo acerca de VESA 75 / 100 adaptation with rotation

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por ITD GmbH.

¿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
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    We have within the framework of our ongoing quality checks unfortunately ascertained that in the case of the article "vesa 75 / 100 adaptation with rotation", which is part of our monitor mounts and support arms, the riveting of the rotation may possibly not have been carried out according to the specifications. in exceptional cases, it can lead to a loosening thereof, respectively to a loosening of the connection plate in the case of continuous use, which can in turn lead to a risk to patients, users or third parties. for this reason we have decided to carry out a replacement action. on account of the fact that no case of damage has hitherto occurred in practice, this relates to preventive measure with regard to our deliveries, for the limited time period from may to november 2015. based on our records, we have discerned that you have been supplied by us, with the affected products, during the aforementioned time period. a detailed list of relevant orders can be found in an annex to this letter. .

Device

VESA 75 / 100 adaptation with rotation

Manufacturer

ITD GmbH
  • Empresa matriz del fabricante (2017)
    Itd Gmbh
  • Source
    AMPMDRS