Events

Retiro De Equipo (Recall) de ProBP 2400 Digital Blood Pressure

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 Welch Allyn Inc.

¿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
    21791
  • Fecha de inicio del evento
    2017-08-14
  • 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: Universal Specialities Ltd trading as USL Medical, 494 Rosebank Road, Avondale, AUCKLAND 1026
  • Causa
    As a result of a defective electrical component in the battery charging circuit, when the probp 2400 is connected to the external power supply/battery charger, a potential over-voltage battery charging condition may occur. this potential defect resides with the device, not the battery., the over-voltage condition can result in high nimh battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic (abs) battery door and other adjacent plastic and foam device components.
  • Acción
    Product to be exchanged

Device

ProBP 2400 Digital Blood Pressure
  • Modelo / Serial
    Model: , Affected: (21)07150001 - (21)07150620, (21)12150001 - (21)12150500
  • Manufacturer
    Welch Allyn Inc

Manufacturer

Welch Allyn Inc