Events

Retiro De Equipo (Recall) de Device Recall Thermo Finnigan ENDURA MD Mass Spectrometer

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Thermo Finnigan LLC.

¿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
    74837
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2775-2016
  • Fecha de inicio del evento
    2016-07-19
  • Fecha de publicación del evento
    2016-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148564
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Mass spectrometer, clinical use - Product Code DOP
  • Causa
    Thermo fisher has determined that the endura md mass spectrometer instrument control software versions 1.0 and 1.0 sp! have a software defect which affect data accuracy.
  • Acción
    ThermoFisher Scientific sent an Urgent Medical Device Field Correction letter dated July 19, 2016, to all affected customers via FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue use of the affected product until a company authorized Field Service Engineer installs corrected software to the instrument system. Customers were also instructed to communicate to all who operate the instrument and to complete the provided Acknowledgment Form, sign, and return it via email FieldActionTeam@thermofisher.com. Customers with questions should contact the Field Action Team at FieldAction@thermofisher.com.

Device

Device Recall Thermo Finnigan ENDURA MD Mass Spectrometer
  • Modelo / Serial
    TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - US including FL, NY and Internationally to Japan.
  • Descripción del producto
    Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. || In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. || Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.
  • Manufacturer
    Thermo Finnigan LLC

Manufacturer

Thermo Finnigan LLC
  • Dirección del fabricante
    Thermo Finnigan LLC, 355 River Oaks Pkwy, San Jose CA 95134-1908
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA