Events

Retiro De Equipo (Recall) de Microcatheter SONIC 1.5F

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getz 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-2017-RN-00618-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-12
  • 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-2017-RN-00618-1
  • 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
    Getz healthcare has been advised by their supplie, balt extrusion, that the manufacture, marketing, distribution, export and use of the microcatheter sonic 1.5f will be temporarily suspended. modifications to sonic 1.5f have been filed with the notified body in europe but the device has been put on the market prior approval. (the manufacturer is awaiting final clearance from the notified body before resupply).
  • Acción
    Getz Healthcare is advising users to inspect their stock and quarantine affected units. Users will be contacted to arrange for the return of their affected units for a credit note or replacement stock to be issued.

Device

Microcatheter SONIC 1.5F
  • Modelo / Serial
    Microcatheter SONIC 1.5FProduct Code: SONIC1.5F25Lot Number: 00268901ARTG Number: 155392
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd