Events

Retiro De Equipo (Recall) de Reusable Stripper and Cleaver Accessories used with Sureflex and Aura Laser Fibers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por American Medical Systems Australia 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-00570-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-25
  • 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-2015-RN-00570-1
  • 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
    American medical systems (ams) has determined that the validation data related to cleaning instructions and sterilisation methods and the methods defined in instructions for use (ifu) do not meet the new guidance on qualifying reusable products.
  • Acción
    AMS is requesting the return of all unused inventory in the field. If the inventory has been used, and has not been discarded, AMS is requesting that the customers discard the devices or return the used device to AMS directly. AMS will be extending a credit to the customers for the purchase price.

Device

Reusable Stripper and Cleaver Accessories used with Sureflex and Aura Laser Fibers

Manufacturer

American Medical Systems Australia Pty Ltd
  • Source
    DHTGA