Events

Retiro De Equipo (Recall) de GE Healthcare DatexOhmeda Aisys

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 Datex - Ohmeda, Inc.

¿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
    36057
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0021-2007
  • Fecha de inicio del evento
    2006-08-10
  • Fecha de publicación del evento
    2006-11-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47879
  • 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
    Anesthesia Delivery System - Product Code BSZ
  • Causa
    Vaporizer shutdown with alarm-an intermittent leak in the aladin 2 cassette/aisys pneumatic interface (valves) may occur that will invoke an alarm state. when this occurs 'vaporizer failure' will appear on the aisys main display, with an accompanying audible alrm. delivery of anesthetic agent is halted; gas flow and ventilation are not affected.
  • Acción
    Firm mailed recall letters on August 10, 2006, to consignees telling them what to do if a failure occurred during system checkout or during use, as a short term solution. Later, GE representatives will make visits to each site for modification of the interface valve on each device, as the long term solution.

Device

GE Healthcare DatexOhmeda Aisys
  • Modelo / Serial
    Serial numbers: ANAK00115, ANAH00114, ANAH00115, ANAH00116, ANAH00117, ANAH00124, ANAH00126, ANAJ00100, ANAJ00101, ANAJ00102, ANAJ00103, ANAJ00104, ANAJ00105, ANAJ00106, ANAJ00107, ANAJ00108, ANAJ00109, ANAJ00110, ANAJ00111, ANAJ00112, ANAJ00113, ANAJ00114, ANAJ00115, ANAJ00116, ANAJ00117, ANAJ00118, ANAJ00119, ANAJ00120, ANAJ00121, ANAJ00122, ANAJ00123, ANAJ00124, ANAJ00125, ANAJ00126, ANAJ00127, ANAJ00128, ANAJ00129, ANAJ00131, ANAJ00132, ANAJ00133, ANAJ00134, ANAJ00135, ANAJ00136, ANAJ00137, ANAJ00138, ANAJ00139, ANAJ00140, ANAJ00141, ANAJ00142, ANAJ00143, ANAJ00144, ANAJ00145, ANAJ00146, ANAJ00147, ANAJ00148, ANAJ00149, ANAJ00150, ANAJ00151, ANAJ00152, ANAJ00153, ANAJ00154, ANAJ00155, ANAJ00156, ANAJ00157, ANAJ00158, ANAJ00159, ANAJ00160, ANAJ00161, ANAJ00162, ANAJ00163, ANAJ00164, ANAJ00165, ANAJ00166, ANAJ00167, ANAJ00168, ANAJ00169, ANAJ00170, ANAJ00171, ANAJ00172, ANAJ00173, ANAJ00174, ANAJ00175, ANAJ00176, ANAJ00177, ANAJ00178, ANAJ00179, ANAJ00180, ANAJ00181, ANAJ00182, ANAJ00183, ANAJ00184, ANAJ00185, ANAJ00186, ANAJ00187, ANAJ00188, ANAJ00189, ANAJ00190, ANAJ00191, ANAJ00192, ANAJ00193, ANAJ00194, ANAJ00195, ANAJ00195, ANAJ00196, ANAJ00197, ANAJ00198, ANAJ00199, ANAJ00200, ANAJ00201, ANAJ00202, ANAJ00203, ANAJ00204, ANAJ00205, ANAJ00206, ANAJ00207, ANAJ00208, ANAJ00209, ANAJ00210, ANAJ00211, ANAJ00212, ANAJ00213, ANAJ00214, ANAJ00215, ANAJ00216, ANAJ00217, ANAJ00218, ANAJ00219, ANAJ00220, ANAJ00221, ANAJ00222, ANAJ00223, ANAJ00224, ANAJ00225, ANAJ00226, ANAJ00227, ANAJ00228, ANAJ00229, ANAJ00230, ANAJ00231, ANAJ00232, ANAJ00233, ANAJ00234, ANAJ00235, ANAJ00236, ANAJ00237, ANAJ00238, ANAJ00239, ANAJ00240, ANAJ00241, ANAJ00242, ANAJ00243, ANAJ00244, ANAJ00245, ANAJ00246, ANAJ00247, ANAJ00248, ANAJ00249, ANAJ00250, ANAJ00251, ANAJ00252, ANAJ00253, ANAJ00254, ANAJ00255, ANAJ00256, ANAJ00257, ANAJ00258, ANAJ00259, ANAJ00260, ANAJ00261, ANAJ00262, ANAJ00263, ANAJ00264, ANAJ00265, ANAJ00266, ANAJ00267, ANAK00100, ANAK00101, ANAK00102, ANAK00103, ANAK00104, ANAK00105, ANAK00106, ANAK00107, ANAK00108, ANAK00109, ANAK00110, ANAK00111, ANAK00112, ANAK00113, ANAK00114, ANAK00116, ANAK00117, ANAK00118, ANAK00119, ANAK00120, ANAK00121, ANAK00122, ANAK00123, ANAK00124, ANAK00125, ANAK00126, ANAK00127, ANAK00128, ANAK00129, ANAK00130, ANAK00131, ANAK00132, ANAK00133, ANAK00134, ANAK00135, ANAK00136, ANAK00137, ANAK00138, ANAK00139, ANAK00140, ANAK00141, ANAK00142, ANAK00143, ANAK00144, ANAK00145, ANAK00146, ANAK00147, ANAK00148, ANAK00149, ANAK00150, ANAK00151, ANAK00152, ANAK00153, ANAK00154, ANAK00155, ANAK00156, ANAK00156, ANAK00157, ANAK00158, ANAK00159, ANAK00160, ANAK00161, ANAK00162, ANAK00163, ANAK00164, ANAK00165, ANAK00166, ANAK00167, ANAK00168, ANAK00169, ANAK00170, ANAK00171, ANAK00172, ANAK00173, ANAK00174, ANAK00175, ANAK00176, ANAK00177, ANAK00178, ANAK00179, ANAK00180, ANAK00181, ANAK00182, ANAK00183, ANAK00184, ANAK00185, ANAK00186, ANAK00187, ANAK00188, ANAK00189, ANAK00190, ANAK00191, ANAK00192, ANAK00193, ANAK00194, ANAK00195, ANAK00196, ANAK00197, ANAK00198, ANAK00199, ANAK00200, ANAK00201, ANAK00202, ANAK00203, ANAK00204, ANAK00205, ANAK00206, ANAK00207, ANAK00208, ANAK00209, ANAK00210, ANAK00211, ANAK00212, ANAK00213, ANAK00214, ANAK00215, ANAK00216, ANAK00217, ANAK00218, ANAK00219, ANAK00220, ANAK00221, ANAK00222, ANAK00223, ANAK00224, ANAK00225, ANAK00226, ANAK00227, ANAK00228, ANAK00229, ANAK00230, ANAK00231, ANAK00232, ANAK00233, ANAK00234, ANAK00235, ANAK00236, ANAK00237, ANAK00238, ANAK00239, ANAK00240, ANAK00241, ANAK00242, ANAK00243, ANAK00244, ANAK00245, ANAK00246, ANAK00247, ANAK00248, ANAK00249, ANAK00250, ANAK00251, ANAK00252, ANAK00253, ANAK00254, ANAK00255, ANAK00256, ANAK00257, ANAK00258, ANAK00259, ANAK00260, ANAK00261, ANAK00262, ANAK00263, ANAK00264, ANAK00265, ANAK00266, ANAK00267, ANAK00268, ANAK00269, ANAK00270, ANAK00271, ANAK00272, ANAK00273, ANAK00274, ANAK00275, ANAK00276, ANAK00277, ANAK00278, ANAK00279, ANAK00280, ANAK00281, ANAK00282, ANAK00283, ANAK00284, ANAK00285, ANAK00286, ANAK00287, ANAK00288, ANAK00289, ANAK00290, ANAK00291, ANAK00292, ANAK00293, ANAK00294, ANAK00295, ANAK00296, ANAK00297, ANAK00298, ANAK00299, ANAK00300, ANAK00301, ANAK00302, ANAK00303, ANAK00304, ANAK00305, ANAK00306, ANAK00307, ANAK00308, ANAK00309, ANAK00310, ANAK00311, ANAK00312, ANAK00313, ANAK00314, ANAK00315, ANAK00316, ANAK00317, ANAK00318, ANAK00319, ANAK00320, ANAK00321, ANAK00322, ANAK00323, ANAK00324, ANAK00325, ANAK00326, ANAK00327, ANAK00329, ANAK00330, ANAK00331, ANAK00332, ANAK00333, ANAK00334, ANAK00335, ANAK00336, ANAK00337, ANAK00338, ANAK00339, ANAK00340, ANAK00341, ANAK00342, ANAK00343, ANAK00344, ANAK00348, ANAK00349, ANAK00350, ANAK00351, ANAK00352, ANAK00353, ANAK00354, ANAK00355, ANAK00356, ANAK00357, ANAK00358, ANAK00359, ANAK00360, ANAK00361, ANAK00362, ANAK00363, ANAK00364, ANAK00365, ANAK00366, ANAK00367, ANAK00368, ANAK00369, ANAK00370, ANAK00371, ANAK00372, ANAK00373, ANAK00374, ANAK00375, ANAK00376, ANAK00377, ANAK00378, ANAK00379, ANAK00380, ANAK00381, ANAK00382, ANAK00383, ANAK00384, ANAK00385, ANAK00386, ANAK00387, ANAK00388, ANAK00389, ANAK00390, ANAK00391, ANAK00392, ANAK00393, ANAK00394, ANAK00395, ANAK00412, ANAK00413, ANAK00414, ANAK00415,
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AK, AL, CA, FL, KS, KY, MD, MN, MO, NC, NE, SC, SD, TX, VA, WI,
  • Descripción del producto
    GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company
  • Manufacturer
    Datex - Ohmeda, Inc

Manufacturer

Datex - Ohmeda, Inc
  • Dirección del fabricante
    Datex - Ohmeda, Inc, Po Box 7550, Madison WI 53707
  • Source
    USFDA