Retiro De Equipo (Recall) de Siemens ADVIA Chemistry Systems software

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Siemens Healthcare Diagnostics Inc.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    The manufacturer has confirmed that three issues have been identified where the system may pass calibration and qc, when it should not., these include auto-calibration with flagged system related errors, auto-calibration with a lot change and reagent pack switching mid-calibration or mid-qc. users are being advised when any of the three situations occur, to perform the calibration or qc again.
  • Acción
    Software to be upgraded


  • Modelo / Serial
    Model: Models: ADVIA 1200, 1650, 1800, 2400, Affected: S/W Versions; V2.00, V2.01 (1200), V3.52, V4.01 (1650), V2.01 91800), V4.01 (2400)
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source