Events

Retiro De Equipo (Recall) de ADVIA CENTAUR CP SYSTEM - INSTRUMENT CLASS IV

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿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
    16141
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-04-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    There are two inaccuracies that exist in the advia centaur cp operator's guide appendix d pre-set tube types. the first refers to the sample volume supported by the system when using the ezee-nest cup to process samples. the operator's guide states that sample volumes greater than 50 ul can be used however volumes greater than 150 ul cannot be used when using an ezee-nest insert cup. the second refers to the use of the universal cup adaptor with an ezee-nest insert cup in 65-mm sample racks. siemens has determined that the height of an ezee-nest insert cup with universal cup adaptor fitted on a 65-mm sample rack will not fit into the sample compartment. no samples will be processed.

Device

ADVIA CENTAUR CP SYSTEM - INSTRUMENT CLASS IV
  • Modelo / Serial
    Model Catalog: 086-A002-01 (Lot serial: ALL); Model Catalog: 09662772 (Lot serial: ALL)
  • Descripción del producto
    ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS IV;ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS III;ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS II
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC