Events

Retiro De Equipo (Recall) de Accu2ipMTA Applicator

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-00759-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-21
  • 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-00759-1
  • 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
    The supplier angiodynamics has identified that the accu2i pmta applicator has the potential to not function as expected during use. the desired microwave energy will not be delivered due to coolant ingress in an electrical connection, this condition results in an error code “high reflective power” displayed on the microwave generator. please note that not all “high reflective power” error codes are a result of this failure mode, as this error code results from any instance where microwave energy is not efficiently transmitted to the tissue. although the specific failure mode of the applicator not delivering the desired microwave energy would not result in any direct harm to the patient; the inserted applicator will need to be removed and replaced in order to continue the procedure.
  • Acción
    Customers are asked to inspect stocks, quarantine all affected units and complete the supplied Facsimile Reply Form to advise as to whether or not you still have stocks of the goods relevant to this recall.

Device

Accu2ipMTA Applicator
  • Modelo / Serial
    Accu2ipMTA ApplicatorProduct Codes: 900-600; 900-601; 900-602Multiple Lot NumbersARTG Number: 174514
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd