BEUDAMED
    FDA Enforcement Class II Terminated

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    Recall: Z-3068-2017 · Reported August 30, 2017

    Enforcement

    Recall Number
    Z-3068-2017
    Event ID
    77380
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 30, 2017
    Initiation Date
    May 23, 2017
    Classification Date
    August 23, 2017
    Termination Date
    May 21, 2020
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782, United States

    Description

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    Reason

    Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.

    Code Info

    H110516, H110619, H110635, H110643, H110624, A110407, A110411, H110507, A110352, A110444, A110417, A110419, H110493, H110494, H110522, H110584, H110586, H110590, H110591, H110559, A110471, A110474, A110355, A110359, H110606, H110566, H110568, H110498, H110503, H110509, H110510, H110637, H110560, H110514, A110427, A110372, A110438, H110587, H110598, H110600, A110439, A110440, A110443, A110450, A110448, A110451, A110453, H110542, H110569, A110445, A110454, H110565, A110356, A110357, H110592, H110593, H110595, A110346, H110508, A110461, H110620, H110623, H110641, H110642, H110613, A110460, A110380, A110463, H110577, A110457, A110401, H110610, H110611, H110502, H110511, H110518, H110519, H110578, H110557, H110561, A110422, A110432, H110512, H110626, H110628, H110629, H110633, H110634, H110539, H110544, A110341, A110418, H110596, H110604, A110387, A110388, H110601, H110615, H110571, H110574, H110599, H110506, A110350, A110398, H110575, A110449, A110360, A110363, A110368, H110554, H110515, H110567, A110410, A110414, A110485, H110553, H110563, H110589, A110376, A110384, H110549, H110564, H110556, H110536, H110646, H110533, H110543, A110458, A110459, A110383, H110538, H110499, A110344, A110345, A110348, A110452, A110391, A110475, A110483, A110486, A110488, A110477, A110479, A110480, A110481, A110482, A110375, A110406, A110470, A110429, A110435, H110618, A110393, A110394, A110447, A110462, A110466, H110555, H110631, H110636, H110639, H110524, H110525, H110526, H110530, H110531, H110532, H110534, H110535, A110476, A110416, A110420, A110379, A110381, A110385, A110484, A110492, H110640, H110579, H110581, H110572, H110573, A110425, A110431, A110441, A110442, H110517, A110426, A110433, A110434, A110353, H110614, H110616, A110464, A110465, H110520, H110523, H110550.

    Distribution

    Nationwide

    Quantity

    US: 116 units