Events

Retiro De Equipo (Recall) de Centricity PACS RA1000 Workstation versions 3.2 and higher (Picture archiving and communication system)

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 IITS 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-2014-RN-00442-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-15
  • 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-2014-RN-00442-1
  • 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
    It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the centricity pacs ra1000 workstation and images are rejected from the active displayed study, images from the previously displayed study may also be rejected. this issue can occur with a previously displayed study that remains open in the background.There is a delrejimg task in centricity pacs versions 3.2 and higher, that if enabled and running, in conjunction with the inadvertently rejected image issue, poses a potential patient safety hazard due to data loss. if the delrejimg task runs, the inadvertently rejected images will be permanently deleted from pacs. if you do not have the delrejimg task running, there is no potential hazard since the inadvertently rejected images remain on the system. the deletion of the inadvertently rejected images could result in missed intervention or mis-diagnosis. no patient injuries have been reported.
  • Acción
    A future release of Centricity PACS will address the unintentional rejected image issue. Until the permanent fix for this issue is deployed, GE recommends customers implement workarounds identified in the customer letter. Also, a GE Healthcare service representative will remove the DelRejImg task from the task table in the Centricity PACS database. This will remove the rejected image deletion feature, and eliminate the hazard situation. Thia action has been closed-out on 28/01/2016.

Device

Centricity PACS RA1000 Workstation versions 3.2 and higher (Picture archiving and communication s...
  • Modelo / Serial
    Centricity PACS RA1000 Workstation versions 3.2 and higher (Picture archiving and communication system)Software versions: 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 3.2 SP7, 3.2 SP8, 4.0, 4.0.1 & 4.0 SP3ARTG number: 162031
  • Manufacturer
    GE Healthcare IITS Australia Pty Ltd

Manufacturer

GE Healthcare IITS Australia Pty Ltd
  • Source
    DHTGA