Events

Retiro De Equipo (Recall) de Philips Brilliance iCTCT Systems 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-01070-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-16
  • 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-01070-1
  • 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 the following issues with brilliance ict s/w v4.1.61. scan parameters exceeds system resources2. scan may start at the top of the head, which may not be where the operator is expecting the scan to start3. error message appears “the exam application stopped working” & will instruct the operator to close the program4. during a bolus tracking procedure, after acquiring the surview, locator & tracker, the scanner may move into place, give patient breathing instructions, & then fail to acquire the scan5. image volumes are not found in patient directory when thin images are included in one of the multiple results6. application may fail when modifying the results plan box during 3d calcium score7. tube too hot8. memory overflow9. while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message10. in the plan viewer, if the start position is modified the total length of the acquisition will change as well.
  • Acción
    Philips Healthcare is notifying the affected users of these issues via this Customer Information Letter. The customers will be contacted by their local Field Service Engineer for implementation of the field correction under FC072800678 to be conducted free of charge to the customer.

Device

Philips Brilliance iCTCT Systems with software version 4.1.6
  • Modelo / Serial
    Philips Brilliance iCTCT Systems with software version 4.1.6Brilliance iCT SP (728311)Brilliance iCT (728306)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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