Events

Retiro De Equipo (Recall) de Ultrasound Transducer Norway TOE

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por GE Vingmed Ultrasound AS.

¿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
    22553
  • Fecha de inicio del evento
    2018-02-07
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    The tristel trio wipes system has been validated for efficacy and residual toxicity for tee probes that do not have visible signs of wear or damage, and when used in connection with shorter procedure times such as cardiac scans., further testing has identified a need for clarification of previously communicated disinfection guidance for ge tee probes. specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods may not always be effective when used in connection with procedures that have long tee probe intubation times, such as cardiac surgeries, and/or with tee probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe.
  • Acción
    Manufacturer to issue advice regarding use

Device

Ultrasound Transducer Norway TOE
  • Modelo / Serial
    Model: TEE probe models 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RS, Affected:
  • Manufacturer
    GE Vingmed Ultrasound AS

Manufacturer

GE Vingmed Ultrasound AS