Events

Retiro De Equipo (Recall) de da Vinci Xi Surgical System P6b Software

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-2017-RN-01543-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-01-04
  • 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-01543-1
  • 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
    Device technologies has learned from the manufacturer, intuitive surgical, that the updated da vinci xi surgical system user manual and the updated da vinci xi instrument and accessory user manual were not provided when the system upgrade was performed. the user manuals will be forwarded to affected customers.
  • Acción
    1. Device Technologies Australia will forward the updated manuals to affected customers. Once the updated System User Manual and the updated Instruments & Accessories User Manual have been received, disregard the previous versions of the system User Manual and the Instruments & Accessories User Manual. 2. Ensure all relevant personnel at your facility are fully informed of this notice, including medical staff who perform da Vinci® XiTM Surgery procedures. 3. Complete and return the supplied Reply Form to acknowledge receipt of this notice. 4. Retain a copy of this letter and the acknowledgement form within the updated System User Manual and the updated Instruments & Accessories User Manual of the da Vinci® XiTM System.

Device

da Vinci Xi Surgical System P6b Software

Manufacturer

Device Technologies Australia Pty Ltd