Events

Notificaciones De Seguridad De Campo acerca de Marus Brand LuxStar Dental Lights

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Marus.

¿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
  • Número del evento
    SN2011(26)
  • Fecha
    2011-11-16
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/marus-brand-luxstar-dental-lights&id=c381f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    Marus has become aware that the lens heat (bulb) shield (birdcage) on the marus luxstar dental lights, model ol1000, may potentially fall off the dental light if not properly installed after replacing the light bulb, or if not properly maintained.
  • Acción
    Marus has been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA), as one of the distributors in Ireland, Dacus Dental, has ceased trading. The serial numbers of the devices provided to Dacus Dental are 4714B and 165569B.  The IMB advises that users:  • Identify the affected devices in your facility.  • Ensure the appropriate personnel are made aware of this notice.  • If you (or your facility) have affected devices, follow the recommendations outlined in the attached Field Safety Notice and contact Marus to obtain the self-installation kit.

Device

Marus Brand LuxStar Dental Lights
  • Modelo / Serial
  • Descripción del producto
    Marus Brand LuxStar Dental Lights
  • Manufacturer
    Marus

Manufacturer

Marus