Retiro De Equipo (Recall) de Device Recall CARESCAPE Monitor B850, B650 or B450

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
    68569
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2085-2014
  • Fecha de inicio del evento
    2014-06-13
  • Fecha de publicación del evento
    2014-07-21
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-09-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Partial loss of monitoring with the carescape monitor b850, b650 or b450. when connecting the pdm (patient data module) to the carescape b850, b650 or b450 monitor with software version 2 the pdm may not start communicating to the monitor and loss of the pdm parameters could occur.
  • Acción
    Consignees were sent on 6/13/2014 a GE Healthcare "Urgent Medical Device Correction" letter #36103, 36104 and 36105 dated June 6, 2014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Products Details, Product Correction and Contact Information. Consignees were advised to contact Technical Support at 800-558-7044 in regard to questions on this recall.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO, MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA.
  • Descripción del producto
    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
  • Manufacturer

Manufacturer

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