Events

Retiro De Equipo (Recall) de GE Healthcare MRI SystemsTwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, & Signa Vibrant Systems

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-2018-RN-00741-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-18
  • 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-00741-1
  • 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 identified that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. if the incorrect version is loaded on the system, the images can be flipped left/right and/or there can be patient data mismatch.
  • Acción
    GE Healthcare are advising they will inspect all affected systems and ensure the proper software version is installed. GE Healthcare will check systems remotely (on-line) where possible, and will visit sites if a remote check is not possible. GE Healthcare will advise users after the software version has been inspected and if any correction is needed. If a correction is needed, a service representative will contact users to arrange for this correction. Users may refer to the information in the Customer Letter to check their system software version. If an impacted system is identified, users are advised to contact their GE representative immediately

Device

GE Healthcare MRI SystemsTwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology...
  • Modelo / Serial
    GE Healthcare MRI SystemsTwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, & Signa Vibrant SystemsMultiple software configurationsARTG Number: 223115(GE Healthcare Australia - MRI system, full-body, superconducting magnet)
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd