Events

Retiro De Equipo (Recall) de WELCH ALLYN PIC 50

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
    33595
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2010-09-20
  • 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
    There is a low potential likelihood for the pic 50 screen display to fail due to a partial or complete dislodging of the cable connecting the screen display to its circuit board. the potential for this failure mode may increase after severe impact to the device. this connection has passed relevant engineering standards and we are not aware of any defect in its design or manufacture.

Device

WELCH ALLYN PIC 50
  • Modelo / Serial
    Model Catalog: 971081E (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 971082E (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 971083E (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 971084E (Lot serial: MORE THAN 10 SERIAL NUMBERS.)
  • Descripción del producto
    WELCH ALLYN PIC 50
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED