Events

Retiro De Equipo (Recall) de STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to final disinfection and sterilisation)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-00323-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-13
  • 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-00323-1
  • 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
    Steris has learned through customer feedback and field service experience that should the caviwave pro ultrasonic cleaning system experience a temporary interruption in electrical power during a processing cycle, it is possible that the circulation pump or ultrasonic generator may stop functioning. the machine does not provide an alert notifying the user of this device malfunction. no injuries or adverse health outcomes have been reported due to this issue.
  • Acción
    Device Technologies representative will contact customers to arrange an upgrade to correct the problem. Customers may continue to operate all Caviwave Pro Ultrasonic Cleaning System and are advised that if they experience a malfunction prior to the upgrade, the equipment in the cycle should be reprocessed. This action has been closed-out on 19/08/2016.

Device

STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to...
  • Modelo / Serial
    STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to final disinfection and sterilisation) Product codes: ST-CRP1172 and ST-CRP1172401 ARTG number: 158370
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd