Events

Retiro De Equipo (Recall) de PROBP 2400

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por WELCH ALLYN CANADA LIMITED.

¿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
    32603
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-04-07
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The manufacturer (microlife corp.) incorrectly installed a component on the printed circuit boards in (2) lots of the probp 2400 during rework in the manufacturing process. as a result of the 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.

Device

PROBP 2400
  • Modelo / Serial
    Model Catalog: 901096 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    PROBP 2400
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED