Events

Retiro De Equipo (Recall) de Philips Brilliance 64, Ingenuity Core128 and Ingenuity CT with software version 4.1.6

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-01387-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-08
  • 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-01387-1
  • 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 have identified multiple issues with the philips brilliance 64 / ingenuity family running software version 4.1.6issue 1: cardiac signal not found in workflow issueissue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to startissue 3: pulmo gates on cardiac workflow issueissue 4: in the plan viewer if the start position is modified the total length of the acquisition will changes as well.Issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results issue 6: application may fail when modifying the results plan box during 3d calcium score issue 7: tube too hot issue 8: memory overflow issueissue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error messageissue 10: issue with the generator monitor state machine in rhost code issuethere have been no injuries reported as a result of these issues.
  • Acción
    Philips is providing users with work around instructions to follow as an interim measure. Philips will be performing a software update as a permanent correction.

Device

Philips Brilliance 64, Ingenuity Core128 and Ingenuity CT with software version 4.1.6
  • Modelo / Serial
    Philips Brilliance 64, Ingenuity Core128 and Ingenuity CT with software version 4.1.6ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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