Events

Notificaciones De Seguridad De Campo acerca de LX3 Microscope Floor Stand

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 Alcon Eye Care UK Limited.

¿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
  • Fecha
    2017-06-01
  • 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
    Alcon has observed that multiple shipments or forceful impact to a caster on a luxor/lx3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base. during in-facility transfer, should a caster break or detach from the base while the microscope arm is not in the most inward locked position (as shown in figure 1), the unit may tip if the microscope arm is extended (as shown in figure 2) over the location of the broken caster. this may lead to the potential for physical injury from the microscope tipping or falling. two incidents of physical injury have been reported in conjunction with this issue. as a precaution, we are voluntarily inspecting and retrofitting luxor / lx3 units with new bases and / or an updated caster configuration. .

Device

LX3 Microscope Floor Stand

Manufacturer

Alcon Eye Care UK Limited
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    AMPMDRS