Events

Retiro De Equipo (Recall) de VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ORTHO-CLINICAL DIAGNOSTICS.

¿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
    95395
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-02-02
  • 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
    Ortho clinical diagnostics has initiated this recall notification due to a possibility of misconfigured electrical wiring in the power system on the vitros 5600 integrated system. this creates a situation where an individual module intended to be shut off will remain on if only the associated power cord is unplugged. note there are two power cords per vitros 5600 system. normal use maintenance and troubleshooting on vitros 5600 systems will not expose an operator to electrical hazards as a result of this issue. the electrical wires are located in an area that is intended to be accessed only by ortho-trained service representatives. there is no risk to ortho-trained service personnel if they follow normal procedures and power off the appropriate module or the vitros 5600 system as a whole prior to working on a component.

Device

VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Modelo / Serial
    Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer)
  • Descripción del producto
    VITROS 5600 Integrated System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS