Events

Retiro De Equipo (Recall) de SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR Systems Elevated temperature of the SENSE Body Coil 1.5T cables

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-00584-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-30
  • 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-00584-1
  • 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
    The instructions for use state how (and how not) to position the sense body coil 1.5t and its cables in relation to the patient and mr bore in order to avoid a hazardous situation. when these instructions are not followed during an examination, the positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to rf coupling to the qbc.
  • Acción
    Philips is reiterating the warnings in the IFU regarding positioning the cables and leads. A sleeve is being developed that will be applied to the cable on the SENSE Body Coil 1.5T and provide consistent spacing between the cable and the patient, thereby reducing the chance of RF interaction and heating.

Device

SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR Systems Elevated temperatu...
  • Modelo / Serial
    SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR SystemsElevated temperature of the SENSE Body Coil 1.5T cablesARTG #: 98887
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA