Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare, Avance, Avance CS2, Amingo.

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
    75584
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0755-2017
  • Fecha de inicio del evento
    2016-11-03
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150848
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Causa
    Ge healthcare has become aware of a potential safety issue where certain avance cs2, avance and amingo anesthesia devices can transition to a system malfunction state if the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force.
  • Acción
    GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 34079 dated November 3, 2016, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Healthcare, Avance, Avance CS2, Amingo.
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA ( nationwide) Distribution including Puerto Rico and DC. and to the countries of Australia AUSTRIA Azerbaijan Bahrain Bangladesh Barbados Belarus Belgium BOLIVIA BOSNIA-HERZEGOVINA Brazil BRUNEI BULGARIA Canada CHILE China COLOMBIA COSTA RICA Croatia Cyprus Czech Republic Denmark ECUADOR Egypt Estonia Ethiopia Finland FRANCE Georgia GERMANY Ghana Gibraltar GREECE HONG KONG HUNGARIA Iceland India Indonesia IRAQ Ireland Israel ITALY JAPAN JORDAN KAZAKHSTAN Kenya KOREA, REPUBLIC OF Kuwait Latvia Lebanon Libyan Arab Jamahiriya LITHUANIA MACEDONIA MALAYSIA Malta Mexico MOLDOVA MOROCCO NAMIBIA Netherlands New Zealand Nicaragua Nigeria NORWAY Oman Pakistan Panama PARAGUAY PERU PHILIPPINES Poland PORTUGAL Qatar ROMANIA Russian Federation Saudi Arabia Serbia SERBIA-MONTENE Singapore Slovakia SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND SYRIA TAIWAN Thailand Tunisia TURKEY Ukraine United Arab Emirates UNITED KINGDOM Uruguay UZBEKISTAN Venezuela VietNam Yemen
  • Descripción del producto
    GE Healthcare, Avance, Avance CS2, Amingo.
  • 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