Events

Retiro De Equipo (Recall) de CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems

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-01062-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-02
  • 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-01062-1
  • 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 customer complaints regarding damage to the external power supply adaptors that accompany the clinitek status, clinitek status+, and clinitek status connect urine analysers, which can result in an increased potential for electric shock to the user. this also includes orderable spare parts.
  • Acción
    If the power supply adaptor is embossed with one of the affected date codes, immediately discontinue use and discard the power supply adaptor. If your power supply adaptor does not have an affected date code, but the case is cracked or damaged in any way, immediately discontinue use and discard the power supply adaptor. This action has been closed-out on 07/06/2016.

Device

CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
  • Modelo / Serial
    CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect SystemsMultiple Siemens Material Numbers and Date Codes affectedARTG Number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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