Events

Retiro De Equipo (Recall) de syngo Imaging XS and syngo.plaza (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-01235-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-24
  • 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-01235-1
  • 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
    Printouts may be printed in incorrect anatomical size when using syngo imaging xs/ syngo.Plaza filming application to print in anatomical size with a printer not appropriate for anatomical printing. this may happen due to an invalid combination of printer and the printer configuration file.
  • Acción
    Only printers identified in the customer letter are validated to be used for anatomical printing. Siemens is recommending users to check their anatomical printouts by using the scale at the right-hand edge of the printout. The distance between two graduation lines corresponds to one centimetre in the anatomy. Please calculate any distances measured on the printout to correspond with this scale prior to printing. If customers have any printer which is not suitable for anatomical printing, they are advised to contact the Siemens Sales Representative. This action has been closed-out on 07/06/2016.

Device

syngo Imaging XS and syngo.plaza (Radiology picture archiving and communication system)
  • Modelo / Serial
    syngo Imaging XS and syngo.plaza (Radiology picture archiving and communication system)syngo Imaging XSModel numbers: 7502029 and 10496279, syngo.plaza Model numbers :10863173, 10592457 and 10863171ARTG number: 120332
  • Manufacturer
    Siemens Ltd

Manufacturer

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