Events

Retiro De Equipo (Recall) de Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with certain PACS systems)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty 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-2013-RN-00326-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-16
  • 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-2013-RN-00326-1
  • 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
    There is an issue related with the direct multi-planar reformat (dmpr) function and screen saved images on the scanner. the dmpr and screen save functionality may possibly generate the same series uid. it has been seen that some picture archiving and communication system (pacs) may combine series under a patient using only the series uid, although all images are correctly annotated. this issue can cause additional images from a different patient and images from two or more patients to appear in one exam. please note that this issue has only been seen on pacs systems manufactured by intelerad (intelepacs 4-3-1-p350 and intelebrowser -4-3-1-p350) at this time.
  • Acción
    GE Healthcare is recommending that customers discontinue using the DMPR functionality, if they are using the above PACS version or if they see similar issues from their current PACS and utilise an alternative capability, such as Batch-mode Reformat on the GE AW, AW server or scanner operator console or 3D reformat save on their 3D PACS viewer. GE Healthcare is planning to implement the permanent correction to affected systems when it is available.

Device

Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with ...
  • Modelo / Serial
    Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with certain PACS systems)ARTG Number: 156650
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd