Events

Retiro De Equipo (Recall) de syngo.plaza(Radiology picture archiving/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-2015-RN-00034-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-15
  • 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-2015-RN-00034-1
  • 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
    In the event of a system crash (e.G. bluescreen, power outage) the image may not be written from cache to the file system and may be lost in syngo.Plaza. when a further image is received, syngo.Plaza will allocate the same file name for the new image, and after some internal checks it will add the entry to the database for the new image. this gives rise to two references in the database to the same image which may lead to either:· the wrong image being displayed, which means for that series there is an image with a wrong examination parameter, and/or wrong examination (e.G. head/knee) and/or may be the wrong patient. this patient mix-up could lead to a wrong diagnosis, or· data loss in that an image is missing.To date this issue has not been reported by australian customers.
  • Acción
    Siemens is providing a work around for customers whilst a permanent software fix is being developed. This action has been closed-out on 15/07/2016.

Device

syngo.plaza(Radiology picture archiving/communication system)
  • Modelo / Serial
    syngo.plaza(Radiology picture archiving/communication system)Lot numbers: 10863171 & 10863173ARTG number: 120332
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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