Events

Retiro De Equipo (Recall) de Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Swirl Technologies Pty Ltd T/A Parker Healthcare.

¿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-00845-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-14
  • 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-00845-1
  • 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 manufacturer has advised that some devices have excessive background noise. this has been determined to be caused by an issue with the transistor circuit.
  • Acción
    Complete the supplied Verification Facsimile/Email Reply Form and then return it as directed to Parker. If any of the investigated products have been transferred to another facility, please immediately let that facility know of this Recall for Product Correction, and record it on the Verification Facsimile/Email Reply Form. If the excessive noise is suspected to be present, or you have any Technical inquiry, please contact Parker Healthcare Service Department as directed. These units will be returned to the Manufacturer in the USA for product correction.

Device

Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular
  • Modelo / Serial
    Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular ARTG Number: 128657 (Swirl Technologies Pty Ltd T/A Parker Healthcare - Ultrasound system, non-imaging, Doppler blood-flow measurement)Serial Number(s):Model: 3 MHz ObstetricSerial Number: CAQ0472
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA