Events

Retiro De Equipo (Recall) de Brilliance iCT and iCT SP, with software versions v4.1.3 and v4.1.5

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-2016-RN-00586-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-12
  • 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-2016-RN-00586-1
  • 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 following issues have been identified which may result in additional patient scanning & therefore additional radiation doses. there have been no reports of injuries as a result of these issues;- scan length changes with a change in the field of view (fov);- the doseright algorithm calculates a water equivalent diameter that is larger than measured on a cylindrical phantom when an 80 kvp or 120 kvp surview is used. this will result in a mas value for the scan that is higher than suggested when using a 100 kvp or 140 kvp surview. (note: the reported mas and ctdi values are correct for all scans & surviews);- wrong scan time estimation due to incorrect intergration time causes the surview scan near 184mm &135mm may result in unexpected scan start positions; &- there may be a discrepancy between the calculated reconstruction length & the actual scan length which may result in the inability to reconstruct the raw data. offline reconstruction of the raw data is also not possible.
  • Acción
    Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Device

Brilliance iCT and iCT SP, with software versions v4.1.3 and v4.1.5

Manufacturer

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