Events

Retiro De Equipo (Recall) de Vivid E9 Ultrasound Systems, software versions 113.0.1 to 113.0.5 when used with probes C1-5-D, C2-9-D, IC-5-9-D and M5Sc-DARTG Number: 146317

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare 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-2014-RN-00411-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-04
  • 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-2014-RN-00411-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (c1-5-d, c2-9-d, ic5-9-d and m5sc-d) are incorrect. this may result in a situation where probes can overheat. if a certain specific hardware failure occurs on the vivid e9 transmitter board (gtx192) this may, in combination with the incorrect power surveillance settings mentioned above, result in an overheating of the probe surface on the listed probes. no overheating of the probes listed above has been reported.
  • Acción
    GE is requesting their customers to cease using the IC5-9-D probe until the systems have been corrected. If any other prodes are observed to be over heating customers should discontinue using the Vivid E9 system and contact GE immediately.

Device

Vivid E9 Ultrasound Systems, software versions 113.0.1 to 113.0.5 when used with probes C1-5-D, C...
  • Modelo / Serial
    Vivid E9 Ultrasound Systems, software versions 113.0.1 to 113.0.5 when used with probes C1-5-D, C2-9-D, IC-5-9-D and M5Sc-DARTG Number: 146317
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd