Events

Retiro De Equipo (Recall) de syngo Lab Data Manager. Middle-ware for use with in vitro diagnostic medical devices (IVD).

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 Diagnostics Division.

¿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-00574-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-22
  • 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-00574-1
  • 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 assay details screen, certain configuration parameters selected during configuration of reference ranges for assays may cause the reference ranges to not hold results as expected. this may cause the release of results to the laboratory information system (lis) that should have been held for manual review.
  • Acción
    Siemens is notifying hospitals and laboratories of specific limitations with the use of sample reports in the syngo Result Manager that have not been previously communicated in the Operator's Guide.

Device

syngo Lab Data Manager. Middle-ware for use with in vitro diagnostic medical devices (IVD).
  • Modelo / Serial
    syngo Lab Data Manager. Middle-ware for use with in vitro diagnostic medical devices (IVD).Software Versions: VA11B, VA12A, VA12BSiemens Material Numbers: 10800057, 10803189, 1084573
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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