Events

Retiro De Equipo (Recall) de MR ACGD Cabinet FRU X Gradient Cable used with GE MRI System Affected Systems: Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi.

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-2015-RN-00675-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-21
  • 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-2015-RN-00675-1
  • 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
    A gradient cable in the acgd cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on x gradient amplifier. this could cause images to be flipped left-right with incorrect orientation annotation. incorrect information taken from study images could result in inappropriate treatment decisions, but should be obvious to the operator. injury or impairment might result if undetected. there have been no injuries reported as a result of this issue.
  • Acción
    GE is advising hospitals that a geometry check will identify if the issue is occurring. A GE Healthcare representative will contact the customer to arrange an appointment to correct the affected device. This action has been closed-out on 15/08/2016.

Device

MR ACGD Cabinet FRU X Gradient Cable used with GE MRI System Affected Systems: Signa Infinity MR ...
  • Modelo / Serial
    MR ACGD Cabinet FRU X Gradient Cable used with GE MRI SystemAffected Systems: Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi.ARTG Number: 223115
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd