Events

Retiro De Equipo (Recall) de GE Healthcare, Aisys, Amingo, Avance, and Avance CS2

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
    66381
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0009-2014
  • Fecha de inicio del evento
    2013-09-16
  • Fecha de publicación del evento
    2013-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122228
  • 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 recently become aware of a potential safety issue involving the avance, avance cs2, and aisys anesthesia devices. while operating in pressure control ventilation  volume guarantee (pcv-vg) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). exposure to excessiv.
  • Acción
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated September 17, 2013. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager, and Director of Biomedical / Clinical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US call 1 800-345-2700, for other countries contact your local GE Healthcare Service Representative).

Device

GE Healthcare, Aisys, Amingo, Avance, and Avance CS2
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico except DE, ME, NM, RI, and VT, and the countries of UNITED ARAB EMIRATES, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA , MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED KINGDOM, VIETNAM, URUGUAY, and VENEZUELA.
  • Descripción del producto
    GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. || Intended for volume or pressure control ventilation.
  • 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