Events

Retiro De Equipo (Recall) de TruVidia Wireless Receiver

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Trumpf Med Aust 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-2018-RN-00075-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-24
  • 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-2018-RN-00075-1
  • 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
    Trumpf medical discovered that the radiated emission from the truvidia wireless receiver is above the normative accepted limits. it is unlikely, but possible, that the radiated emission may interact with other devices in the operating room, which may cause other devices to not function properly. the frequency of interference and associated risk will be dependent upon the immunity of the other devices for radiated emissions and nature of the failure mode of the operating room equipment being used at the time.
  • Acción
    Trumpf Medical is advising users that an upgrade of the affected components will be completed as a permanent correction. If users suspect that the device may be interacting with other devices in the operating room, switch off the wireless receiver (ensure the receiver is switched off, it is not sufficient to switch off the camera or control unit).

Device

TruVidia Wireless Receiver
  • Modelo / Serial
    TruVidia Wireless Receiver Model Number: 1940747Serial Number: 102584474 to 103214022ARTG Number 274674
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd