Events

Retiro De Equipo (Recall) de Philips Advia Chemistry XPT System

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
    Recall
  • ID del evento
    20430
  • Fecha de inicio del evento
    2016-07-25
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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
    Siemens healthcare diagnostics has identified an issue with the ratio equation provided on the advia® chemistry xpt system software test definition (tdef) version 1.0 disks (smn: 11127343 and 11222123). this issue affects only the advia chemistry hemoglobin a1c_3 automated pretreatment (a1c_3) results when hba1c values are reported in international federation of clinical chemistry (ifcc) equivalent units (hba1cr).
  • Acción
    Manufacturer to issue advice regarding use

Device

Philips Advia Chemistry XPT System
  • Modelo / Serial
    Model: Advia Chemistry XPT System, Affected: Material Number 10723034, Software version: Version 1.0 disks
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA