BEUDAMED
    FDA Enforcement Class II Terminated

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    Recall: Z-0188-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0188-2014
    Event ID
    66726
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    October 17, 2013
    Classification Date
    November 8, 2013
    Termination Date
    February 25, 2014
    Address
    35301 Se Center St, Snoqualmie, WA, 98065-9216, United States

    Description

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    Reason

    Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.

    Code Info

    SERIAL NUMBER IN THE US: 3300-203410 SERIAL NUMBERS INTERNATIONAL: 3300-203361, 3300-203362, 3300-203363, 3300-203364, 3300-203386, 3300-203387, 3300-203388, 3300-203389, 3300-203390, 3300-203391, 3300-203392, 3300-203393, 3300-203394, 3300-203395, 3300-203396, 3300-203397, 3300-203398, 3300-203399, 3300-203400, 3300-203401, 3300-203402, 3300-203403, 3300-203404, 3300-203405, 3300-203406, 3300-203407, 3300-203408, 3300-203409, 3300-203410, 3300-203443, 3300-203444, 3300-203445, 3300-203446, 3300-203447, 3300-203448, 3300-203449, 3300-203450, 3300-203451, 3300-203452, 3300-203453, 3300-203454, 3300-203455, 3300-203456, 3300-203457, 3300-203458, 3300-203459, 3300-203460, 3300-203461, 3300-203462, 3300-203463, 3300-203464, 3300-203465, 3300-203466, 3300-203467, 3300-203468, 3300-203469, 3300-203470, 3300-203471, 3300-203472, 3300-203473, 3300-203474, 3300-203475, 3300-203476, 3300-203477, 3300-203478, 3300-203479, 3300-203480, 3300-203481, 3300-203482, 3300-203483, 3300-203484, 3300-203485, 3300-203486, 3300-203487, 3300-203488, 3300-203489, 3300-203490, 3300-203491, 3300-203492, 3300-203501, 3300-203502, 3300-203503, 3300-203504, 3300-203505, 3300-203506, 3300-203507, 3300-203508, 3300-203509, and 3300-203511.

    Distribution

    Worldwide Distribution-Distributed in Puerto Rico and the countries of France, Indonesia, Korea, Nicaragua, Philippines, and Taiwan.

    Quantity

    89 units total (1 in US and 88 International)