Events

Retiro De Equipo (Recall) de Device Recall Aespire, Aestiva, Aisys, Avance, Anesthesia device service kits

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 Medical Systems, 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
    72943
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0682-2016
  • Fecha de inicio del evento
    2015-12-15
  • Fecha de publicación del evento
    2016-01-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142568
  • 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
    The drive gas check valve of certain anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. if this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
  • Acción
    GE Healthcare sent an Urgent Medical Device Correction letter dated December 15, 2015, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.

Device

Device Recall Aespire, Aestiva, Aisys, Avance, Anesthesia device service kits
  • Modelo / Serial
    11328664 11335735 11343334 11343892 11342401-2 5400168 5403740-1 5403740-2  11335499 11345497 11340364 11320301-1 11320301-2 11330567 11331744 11307341 11331786 11335845 11335293 11319820 11321192 11321193 11327291 11322915 11332821 11326031 11330266 11313876 11331340 11304929 11336322 11336553 11315455 11325139 11326345 11335028-1 11335028-2 11305735 11322211 11323901 6514379 6514380 11307579 11307579 11321258 5398226 5405405 11337945 5404884 5405628 5406602 5401553-1 5401553-2 5402221-1 5402221-2 5402221-3 5404056-1 5404056-2 5404550-1 5404550-2 5404550-3 5404550-4 5405413-1 5405413-2 5405413-3 5405699-1 5405699-2 5405699-3 11009279 5405867 5405868 5398018-1 5398018-2 5404050-1 5404050-2 5405504-1 5405504-2  11320017 11324236 11311155 11342043 5401539 5401527-1 5401527-2 5401527-3 5401527-4 11315668 5401531  11334842 11305495 11333980 11339911 11330029-2 11308028 11323566 11323905 5406531  11334842 11305495 11333980 11339911 11330029-2 11308028 11323566 11323905 5406531
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
  • Descripción del producto
    Anesthesia device service kits. || ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 || ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 || ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 || ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 || ASSY-MSN, VLV ASSY DR GAS CHK BCG, Manufacturing assembly - Buy || 1503-3006-000 || Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected and could have been installed on Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2 Anesthesia, and Amingo devices. (Service kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000, 1503-8101-000).
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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