Events

Retiro De Equipo (Recall) de DIGITAL BLOOD PRESSURE MONITOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS LTD..

¿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
    71445
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-10-26
  • 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
    A&d may have shipped blood pressure monitors that were not labeled for use with small cuff. the device is intended to be used with arm sizes from 5.1 inches to 17.7 inches or small cuffs (6.3-9.4") medium cuffs ( 9.4-14.2") and large cuffs (14.2-17.7"). for optimal comfort the manufacturer adjusts the exhaust valve for the devices to be used with a small cuff. in doing so the manufacturer may have not provided clear labeling on the front of these devices to indicate they have been adjusted for small cuff use. additionally some devices may have been labeled "adjusted for small cuffs" but may have been equipped with a medium cuff.

Device

DIGITAL BLOOD PRESSURE MONITOR
  • Modelo / Serial
    Model Catalog: UA-767PBT-CI (Lot serial: 5150402416); Model Catalog: UA-767PBT-CI (Lot serial: 5150402411)
  • Descripción del producto
    Digital Pressure Monitor
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC