Retiro De Equipo (Recall) de NDI Disposable Reflective Marker Spheres (reflective marker spheres for use with Brainlab image-guided surgery systems)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Life Healthcare Pty 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
    RC-2015-RN-00502-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-12
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Ndi determined that drms spheres from lot c102061501 may break apart at the mid-point where the two halves of the sphere are sealedtogether, either during installation onto reference arrays or surgical tools (i.E., when threading them onto posts), or any time during a surgical procedure.One failure of this nature has been reported, with no report of injury or death.
  • Acción
    Life Healthcare is requesting their customers to quarantine any affected stock. Life Healthcare will provide replacement stock where required. This action has been closed-out on 10/08/2016.

Device

  • Modelo / Serial
    NDI Disposable Reflective Marker Spheres (reflective marker spheres for use with Brainlab image-guided surgery systems)Lot C102061501ARTG Number: 182255
  • Manufacturer

Manufacturer