Events

Retiro De Equipo (Recall) de GE LOGIQ S8 and LOQIQ S7 Ultrasound

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 Ultrasound Korea 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
    14572
  • Fecha de inicio del evento
    2013-04-30
  • 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
    Manufacturer has recently become aware of a potential safety issue due to the s4-10-d ultrasound probe used in conjunction with the logiq s8 and logiq s7 ultrasound systems. it was also discovered that this issue also leads to a specification issue of the acoustic output of this probe, there is a potential for a skin burn when the flow model in the cardiac application is activated with the s4-10-d ultrasound probe.
  • Acción
    Software to be upgraded

Device

GE LOGIQ S8 and LOQIQ S7 Ultrasound
  • Modelo / Serial
    Model: , Affected: with software revisions R.1.1.1 , R1.5.1 and R1.0.1, R1.0.2 and R1.0.3
  • Manufacturer
    GE Ultrasound Korea Ltd

Manufacturer

GE Ultrasound Korea Ltd