Events

Retiro De Equipo (Recall) de Dimension Integrated Chemistry Systems

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 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
    70913
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1615-2015
  • Fecha de inicio del evento
    2015-04-02
  • Fecha de publicación del evento
    2015-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135513
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Certain dimension integrated chemistry systems instrument power configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. the likelihood of potential clinical impact or injury due to this issue is extremely low.
  • Acción
    Siemens sent an Urgent Field Safety Notice, dated April 2015, was issued for distribution to affected customers in Japan to notify them of the issue. A Siemens Service Representative will visit customer sites to inspect the Dimension instrument power plug and wall outlet configuration. If the instrument is configured with a non-standard 15 Amp plug/outlet or a 20 Amp twist lock plug, Siemens will correct the issue identified, ensuring that the system is installed according to the instrument requirements.

Device

Dimension Integrated Chemistry Systems
  • Modelo / Serial
    Model numbers: D045912, D193440, D140066;  Material Numbers: 10472176, 10636928, 10465412, 10461038, 10444828, 10444829, 10461849, 10461043, 10444837, 10444838
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the country of Japan.
  • Descripción del producto
    Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. || The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA