Events

Retiro De Equipo (Recall) de syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiology 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 Siemens 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-00425-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-17
  • 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-00425-1
  • 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
    Sensis reference numbers greater than 1,000,000 are wrongly modified during transfer to syngo dynamics. in this case during “in-progress” a study will get a sensisrefno for the wrong study in sensis. this will cause an incorrect link between syngo dynamics images and the sensis study data. when a patient study is opened in syngo dynamics a sensis report of another patient study is shown.The preconditions for this to occur are:- sensis-syngo dynamics integration- sensis study is opened from syngo dynamics while still "in progress"- sensis reference number is > 1000,000this could result in patient mismatch or a persistent unintended change to patient data could result. the patient mismatch is detectable when the study is opened for the first time if the toolbar is not configured to auto-hide.
  • Acción
    Siemens is preparing a service patch modification that will resolve the potential malfunction. In the interim, end users are requested to discontinue opening "in progress" studies and to configure the “AXIOM Artis AE” title in syngo Dynamics to "Other" type of station. This action has been closed-out on 02/02/2016.

Device

syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiology picture archiving and commu...
  • Modelo / Serial
    syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiology picture archiving and communication system)ARTG number: 120332
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA