Events

Retiro De Equipo (Recall) de Device Recall GE Healthcarr Dash Port 2 Docking Station

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 GE Healthcare, 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
    63662
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0814-2013
  • Fecha de inicio del evento
    2012-06-13
  • Fecha de publicación del evento
    2013-02-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114428
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    Ge has become aware of multiple issues affecting the dash 3000/4000/5000 and dashport 2 monitor. this report of correction encompasses the dashport 2 device, in which the dashport 2 stops communicating with the dash, resulting in loss of monitoring at the cic. the dashport 2 status leds in the back of the unit indicate unity network and dashport 2 to dash communication has stopped.
  • Acción
    GE Healthcare sent an Important Product Information Letter dated June 13, 2012 via FedEx to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter indicated that the motherboard would be replaced, on request, should the customer continue to experience the issue. A second letter dated August 30th 2012 was issued informing consignees that the correction that was initially proposed did not fully correct the issues. Therefore, the motherboard replacement field action had been suspended. It further explained that the correction will be provided at no charge when it is available. For questions contact Technical Support at 1-800-558-7044.

Device

Device Recall GE Healthcarr Dash Port 2 Docking Station
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution and US (nationwide) including DC and the countries of ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, INDIA, ISRAEL, ITA LY, JAPAN, JORDAN, KUWAIT, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH KOREA, SPAIN SWEDEN SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.
  • Descripción del producto
    GE Healthcare, Dash Port 2 Docking Station. || Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Dirección del fabricante
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA