Events

Retiro De Equipo (Recall) de PEB01H Diathermy Pencil (Electrosurgical electrode)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Med-Chem Surgical 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-2013-RN-01032-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-10
  • 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-2013-RN-01032-1
  • 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
    Med-chem surgical has received reports of the affected batch of diathermy pencils ceasing to function during use.
  • Acción
    Med-Chem Surgical is requesting their customers to inspect their stock and quarantine any units from batch 1303141. Recovery and replacement of stock will be arranged once customers confirm they are affected by the recall.

Device

PEB01H Diathermy Pencil (Electrosurgical electrode)
  • Modelo / Serial
    PEB01H Diathermy Pencil (Electrosurgical electrode)Batch Number: 1303141ARTG Number: 174598
  • Manufacturer
    Med-Chem Surgical Pty Ltd

Manufacturer

Med-Chem Surgical Pty Ltd
  • Source
    DHTGA