BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients

    Recall: Z-1376-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1376-2015
    Event ID
    70677
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    February 27, 2015
    Classification Date
    April 2, 2015
    Termination Date
    April 16, 2015
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients

    Reason

    Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. This could result in a blank display or loss of mechanical ventilation.

    Code Info

    Mfg Lot or Serial # ANCU00179 ANCU00114 ANCU00115 ANCU00116 ANCU00117 ANCU00118 ANCU00119 ANCU00120 ANCU00121 ANCU00178 ANCU00105 ANCU00123 ANCU00124 ANCU00125 ANCU00129 ANCU00130 ANCU00126 ANCU00108 ANCU00113 ANCU00112 ANCU00193 ANCU00174 ANCU00137 ANCU00175 ANCU00134 ANCU00135 ANCU00136 ANCU00150 ANCU00151 ANCU00138 ANCU00152 ANCU00140 ANCU00172 ANCU00139 ANCU00153 ANCU00141 ANCU00142 ANCU00143 ANCU00149 ANCU00147 ANCU00148 ANCU00146 ANCU00145 ANCU00101 ANCU00102 ANCU00103

    Distribution

    Worldwide Distribution -- US, including the states of NC and OK; and the countries of CHINA, INDIA, JAPAN, MEXICO, and VENEZUELA.

    Quantity

    46 (10 units US, 36 units OUS)