Retiro De Equipo (Recall) de syngo Lab Data Manager with software version VA12B. (Software used to supplement operational functions). An in vitro diagnostic medical device (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 Healthcare Pty 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-00842-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-31
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Siemens has identified the following five system software feature issues with the syngo lab data manager:- - result unit conversion;- quality control processing;- virus protection; - system performance degradation; and- order received from lis is rejected.If an issue were to exist the user would be made aware via system alerts, quality control processing status or standard syngo ldm rule validation.
  • Acción
    Siemens is providing system configuration modifications to correct the identified issues. Siemens is not recommending a look back of previously generated results.

Device

  • Modelo / Serial
    syngo Lab Data Manager with software version VA12B. (Software used to supplement operational functions). An in vitro diagnostic medical device (IVD) ARTG Number: 224616
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA