Events

Retiro De Equipo (Recall) de StreamLAB Automation Solutions (Clinical Chemistry Sample Processors). 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 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-2012-RN-01047-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-16
  • 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-2012-RN-01047-1
  • 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
    Siemens healthcare diagnostics has received reports from customers that the small pins at the bottom of the centre door panel of the input/output module, which protrude approximately 5/8 inch, have contributed to a trip and fall incident. customers are being asked to use caution when working in the area of the input/output module and to post the communication near or on the streamlab analytical workcell system.
  • Acción
    Siemens is providing work around instructions for users to implement.

Device

StreamLAB Automation Solutions (Clinical Chemistry Sample Processors). An in-vitro diagnostic med...
  • Modelo / Serial
    StreamLAB Automation Solutions (Clinical Chemistry Sample Processors). An in-vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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