Events

Retiro De Equipo (Recall) de syngo Workflow SLR with versions VA31, VA32, VB10, or VB20A (TBC)(Radiology information 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-00443-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-28
  • 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-00443-1
  • 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
    While configured for the batching of orders, when an order transaction is received from a his interface, it is temporarily read into the system while waiting for the next transaction to come across the interface. if the next transaction is another procedure for the same patient, it would be "batched" with the first order until a transaction that is not an order for the "batched" patient is received or the maximum wait time of 10 seconds is exceeded. at this point, all the order(s) would be processed.If the system receives a shutdown request to restart the interface process while an order is within this 10 second "batching" window, the order may be lost with no indication to the user. this condition can happen when a user manually attempts to restart the interface process or when all of the application processes are restarted during the day-end processing sequence.
  • Acción
    The issue can be avoided by not using the Order Batching feature. If the Order Batching feature is used. Users are recommended to configure the day-end processing to take place at the time with the anticipated lowest number of order transactions until the issue is solved in the software.For new upgrades or new installations, the issue will be solved in the syngo Workflow SLR software version VB20A_HF01 which is planned to be released in 02/2015. For existing VA31, VA32, VB10, and VB20A sites, the issue will be resolved following Safety Update Instruction SY038/15/S which is planned to be released in 02/2015. This action has been closed-out on 31/08/2016.

Device

syngo Workflow SLR with versions VA31, VA32, VB10, or VB20A (TBC)(Radiology information system)
  • Modelo / Serial
    syngo Workflow SLR with versions VA31, VA32, VB10, or VB20A (TBC)(Radiology information system) Catalogue number: 10558586ARTG number: 142663
  • Manufacturer
    Siemens Ltd

Manufacturer

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