Events

Retiro De Equipo (Recall) de VITROS 5600 Integrated System. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia 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
    RC-2016-RN-00228-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-29
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00228-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Ortho is providing information regarding the potential for four wires connected to the power supply to have been misconfigured within vitros 5600 system(s) during manufacturing. the electrical wires are located in an area that is intended to be accessed only by an ortho-trained service representative. normal use, maintenance and troubleshooting on vitros 5600 system will not expose an operator to electrical hazards as a result of this issue.If a system has the incorrect wire configuration, it is possible that if the power to an individual module is intended to be shut off, it will remain on. however, 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.
  • Acción
    Customers are advised that there is no impact to the results generated with an affected system. An Ortho representative will be inspecting the wiring of all affected systems and will reconfigure the wiring where required. This action has been closed-out on 09/05/2017.

Device

VITROS 5600 Integrated System. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS 5600 Integrated System. An in vitro diagnostic medical device (IVD)Product Codes: 6802413 and 6802915ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics