Device Recall BladderScan BVI 9600 with Aorta Scan Mode

  • Modèle / numéro de série
    Serial numbers:   B6001061, B6001062, B6001063, B6001064, B6001065, B6001066, B6001067, B6001068, B6001069, B6001070, B6001071, B6001072, B6001073, B6001074, B6001075, B6001076, B6001077, B6001078, B6001079, B6001080, B6001081, B6001082, B6001083, B6001084, B6001085, B6001086, B6001088, B6001090, B6001092, B6001093, B6001097, B6001098, B6001103, B6001104, B6001107, B6001108, B6001109, B6001110, B6001111, B6001112, B6001113, B6001134, B6001164, B6001166, B6001167, B6001168, B6001169, B6001170, B6001172, B6001173, B6001174, B6001175, B6001176, B6001177, B6001178, B6001179, B6001181, B6001184, B6001185, B6001186, B6001187, B6001188, B6001189, B6001190, B6001191, B6001192, B6001198, B6001199, B6001200, B6001201, B6001202, B6001203, B6001204, B6001205, B6001206, B6001207, B6001208, B6001209, B6001211, B6001212, B6001213, B6001215, B6001216, B6001217, B6001218, B6001219, B6001220, B6001221, B6001223, B6001224, B6001225, B6001232, B6001233, B6001234, B6001239, B6001240, B6001242, B6001243, B6001244, B6001245, B6001251, B6001253, B6001254, B6001255, B6001256, B6001257, B6001258, B6001259, B6001260, B6001261, B6001263, B6001265, B6001267, B6001269, B6001270, B6001271, B6001272, B6001273, B6001277, B6001278, B6001279, B6001280, B6001281, B6001282, B6001283, B6001284, B6001285, B6001286, B6001287, B6001288, B6001289, B6001290, B6001291, B6001292, B6001293, B6001294, B6001295, B6001296, B6001297, B6001298, B6001299, B6001300, B6001301, B6001302, B6001305, B6001306, B6001307, B6001308, B6001309, B6001310, B6001311, B6001312, B6001313, B6001314, B6001315, B6001316, B6001317, B6001318, B6001319, B6001320, B6001321, B6001322, B6001323, B6001324, B6001325, B6001326, B6001327, B6001328, B6001329, B6001330, B6001331, B6001332, B6001333, B6001336, B6001337, B6001338, B6001339, B6001340, B6001341, B6001342, B6001343, B6001345, B6001346, B6001347, B6001348, B6001349, B6001350, B6001351, B6001353, B6001354, B6001355, B6001356, B6001357, B6001358, B6001359, B6001360, B6001361, B6001362, B6001363, B6001364, B6001365, B6001366, B6001367, B6001368, B6001369, B6001370, B6001371, B6001372, B6001373, B6001374, B6001375, B6001377, B6001378, B6001379, B6001380, B6001381, B6001382, B6001383, B6001384, B6001385, B6001386, B6001387, B6001388, B6001389, B6001390, B6001391, B6001392, B6001393, B6001394, B6001395, B6001396, B6001397, B6001398, B6001399, B6001401, B6001402, B6001403, B6001404, B6001405, B6001406, B6001407, B6001408, B6001409, B6001410, B6001411, B6001413, B6001415, B6001416, B6001418, B6001419, B6001421, B6001422, B6001423, B6001424, B6001425, B6001426, B6001427, B6001432, B6001433, B6001435, B6001436, B6001437, B6001438, B6001439, B6001440, B6001441, B6001442, B6001443, B6001444, B6001445, B6001446, B6001447, B6001448, B6001449, B6001450, B6001451, B6001452, B6001453, B6001454, B6001455, B6001456, B6001457, B6001463, B6001464, B6001465, B6001466, B6001467, B6001468, B6001469, B6001470, B6001471, B6001472, B6001473, B6001474, B6001475, B6001476, B6001477, B6001478, B6001479, B6001481, B6001482, B6001483, B6001485, B6001486, B6001487, B6001488, B6001489, B6001490, B6001491, B6001492, B6001493, B6001495, B6001496, B6001497, B6001498, B6001499, B6001500, B6001501, B6001502, B6001503, B6001505, B6001506, B6001507, B6001508, B6001509, B6001510, B6001511, B6001512, B6001513, B6001514, B6001516, B6001517, B6001518, B6001519, B6001520, B6001522, B6001523, B6001524, B6001525, B6001529, B6001530, B6001532, B6001533, B6001534, B6001539, B6001540, B6001542, B6001545, B6001547, B6001548, and B6001549.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.
  • Description du dispositif
    BVI 9600 Bladder Volume Instrument, Aorta Scan Mode || The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Société-mère du fabricant (2017)
  • Source
    USFDA