Events

Retiro De Equipo (Recall) de Natus - Phototherapy unit

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Natus Medical Incorporated.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    21477
  • Fecha de inicio del evento
    2017-06-13
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Paragon Medical Ltd t/a LR Instruments and Scanmedics, c/o MediRay, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Causa
    The manufacturer is in the process of confirming an updated neoblue blanket configuration which will not be susceptible to the degradation. however, the date of project completion is uncertain at this time. the manufacturer will contact you when the new configuration is available.
  • Acción
    Product to be modified

Device

Natus - Phototherapy unit
  • Modelo / Serial
    Model: , Affected: serial numbers 002534, 002535, 452001642 and 452001643, 65536 and 65537
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated