Events

Retiro De Equipo (Recall) de Ingenuity TF PET/CT running software version 4.0.2 (4.0.0.26645)

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-2017-RN-01541-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-21
  • 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-2017-RN-01541-1
  • 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
    Philips has identified a software issue causing pet reconstructions to fail intermittently. it was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. this error has been found to occur in two scenarios resulting in acquisition data that will not be able to be reconstructed and will therefore be unusable: 1) when the system operator cancels an acquisition2) couch position requests within the software sequence were delayed a. the error occurs intermittently, but has been found to occur more frequently when the gantry’s network is heavily loaded with multiple retrospective reconstructions running in parallel. b.The error manifests to the technologist by an error message and failed status on the reconstruction monitor and the error message “result {0} failed to reconstruct” on the acquisition workflow window during reconstruction after the patient scan has been completed.
  • Acción
    It is recommended that the technologist follow the Warning provided in the Instructions for Use - System Information for Ingenuity TF 459800079321 Rev B, Section 2 Safety Guidelines, pg 2-17 and that the patient remains in the original scan position until reconstructed images are verified. Philips will be releasing a correction for this issue. A Philips Field Service Engineer will contact users to schedule the update.

Device

Ingenuity TF PET/CT running software version 4.0.2 (4.0.0.26645)

Manufacturer

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