Class 2 Device Recall BladderScan BVI 9600 or AortaScan AMI 9700

• Date Initiated by Firm: November 30, 2015
• Create Date: March 10, 2016
• Recall Status: Terminated on October 12, 2016
• Recall Number: Z-1091-2016
• Recall Event ID: 72486
• 510(K)Number: K082456
• Product Classification: System, imaging, pulsed echo, ultrasonic - Product Code IYO
• Product: BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.
• Code Information: SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA **************** A7001001, A7001002, A7001005, A7001007, A7001011, A7001022, A7001024, A7001031, A7001034, A7001036, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001060, A7001062, A7001065, A7001067, A7001068, A7001079, A7001080, A7001086, A7001088, A7001093, A7001094, A7001098, A7001101, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001126, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001138, A7001139, A7001140, A7001141, A7001143, A7001144, A7001146, A7001147, A7001148, A7001150, A7001151, A7001152, A7001153, A7001155, A7001156, A7001157, A7001158, A7001161, A7001162, A7001163, A7001164, A7001165, A7001168, A7001169, A7001170, A7001171, A7001172, A7001173, A7001174, A7001175, A7001176, A7001177, A7001178, A7001179, A7001180, A7001181, A7001182, A7001183, A7001184, A7001185, A7001186, A7001187, A7001188, A7001189, A7001190, A7001191, A7001192, A7001194, A7001195, A7001196, A7001197, A7001198, A7001199, A7001201, A7001202, A7001204, A7001205, A7001206, A7001207, A7001209, A7001210, A7001211, A7001212, A7001216, A7001217, A7001218, A7001219, A7001220, A7001221, A7001222, A7001223, A7001224, A7001226, A7001227, A7001228, A7001229, A7001231, A7001232, A7001233, A7001234, A7001235, A7001236, A7001237, A7001238, A7001239, A7001240, A7001241, A7001242, A7001243, A7001244, A7001246, A7001247, A7001248, A7001249, A7001250, A7001251, A7001252, A7001253, A7001254, A7001255, A7001256, A7001257, A7001258, A7001260, A7001261, A7001262, A7001264, A7001265, A7001266, A7001268, A7001269, A7001270, A7001271, A7001272, A7001273, A7001275, A7001276, A7001277, A7001278, A7001279, A7001281, A7001283, A7001284, A7001285, A7001286, A7001287, A7001288, A7001289, A7001290, A7001291, A7001292, A7001293, A7001294, A7001295, A7001296, A7001297, A7001298, A7001299, A7001300, A7001301, A7001302, A7001303, A7001305, A7001306, A7001307, A7001308, A7001312, A7001313, A7001314, A7001315, A7001316, A7001317, A7001318, A7001319, A7001320, A7001321, A7001322, A7001323, A7001324, A7001325, A7001326, A7001327, A7001328, A7001329, A7001330, A7001331, A7001332, A7001333, A7001334, A7001335, A7001336, A7001337, A7001338, A7001339, A7001340, A7001341, A7001342, A7001343, A7001344, A7001345, A7001347, A7001348, A7001349, A7001350, A7001351, A7001352, A7001353, A7001354, A7001355, A7001356, A7001357, A7001358, A7001359, A7001360, A7001361, A7001362, A7001363, A7001364, A7001365, A7001366, A7001367, A7001369, A7001370, A7001371, A7001372, A7001373, A7001375, A7001376, A7001377, A7001378, A7001380, A7001381, A7001382, A7001383, A7001384, A7001385, A7001386, A7001387, A7001388, A7001389, A7001390, A7001391, A7001392, A7001393, A7001394, A7001395, A7001396, A7001397, A7001398, A7001399, A7001400, A7001401, A7001402, A7001403, A7001404, A7001405, A7001406, A7001408, A7001409, A7001410, A7001411, A7001412, A7001413, A7001414, A7001415, A7001416, A7001418, A7001419, A7001420, A7001421, A7001422, A7001423, A7001424, A7001425, A7001426, A7001427, A7001428, A7001429, A7001430, A7001431, A7001432, A7001433, A7001434, A7001435, A7001436, A7001437, A7001438, A7001439, A7001440, A7001441, A7001445, A7001446, A7001447, A7001448, A7001449, A7001450, A7001451, A7001452, A7001453, A7001454, A7001455, A7001456, A7001457, A7001458, A7001459, A7001460, A7001461, A7001462, A7001463, A7001464, A7001465, A7001466, A7001467, A7001468, A7001469, A7001470, A7001471, A7001472, A7001473, A7001474, A7001475, A7001476, A7001477, A7001478, A7001479, A7001480, A7001482, A7001483, A7001484, A7001485, A7001486, A7001487, A7001488, A7001489, A7001490, A7001491, A7001492, A7001493, A7001494, A7001495, A7001496, A7001498, A7001499, A7001500, A7001502, A7001503, A7001504, A7001505, A7001506, A7001507, A7001508, A7001509, A7001510, A7001511, A7001512, A7001513, A7001514, A7001515, A7001516, A7001517, A7001518, A7001519, A7001520, A7001521, A7001522, A7001523, A7001524, A7001525, A7001526, A7001527, A7001528, A7001529, A7001530, A7001531, A7001532, A7001533, A7001534, A7001535, A7001536, A7001537, A7001538, A7001539, A7001540, A7001541, A7001542, A7001543, A7001544, A7001545, A7001546, A7001547, A7001548, A7001549, A7001550, A7001551, A7001552, A7001553, A7001554, A7001555, A7001556, A7001557, A7001558, A7001559, A7001560, A7001561, A7001562, A7001563, A7001564, A7001565, A7001566, A7001567, A7001568, A7001569, A7001570, A7001571, A7001572, A7001573, A7001574, A7001575, A7001576, A7001577, A7001578, A7001579, A7001580, A7001581, A7001582, A7001583, A7001584, A7001585, A7001586, A7001587, A7001588, A7001589, A7001590, A7001591, A7001592, A7001593, A7001594, A7001595, A7001596, A7001597, A7001598, A7001599, A7001600, A7001601, A7001602, A7001603, A7001604, A7001605, A7001606, A7001607, A7001608, A7001609, A7001610, A7001611, A7001612, A7001613, A7001614, A7001615, A7001616, A7001617, A7001618, A7001619, A7001620, A7001621, A7001622, A7001623, A7001624, A7001625, A7001626, A7001628, A7001629, A7001630, A7001631, A7001632, A7001633, A7001634, A7001635, A7001636, A7001637, A7001638, A7001639, A7001640, A7001641, A7001642, A7001643, A7001644, A7001645, A7001646, A7001647, A7001648, A7001649, A7001650, A7001651, A7001652, A7001653, A7001654, A7001655, A7001656, A7001657, A7001658, A7001659, A7001660, A7001661, A7001662, A7001663, A7001664, A7001665, A7001666, A7001667, A7001668, A7001669, A7001670, A7001671, A7001672, A7001673, A7001674, A7001675, A7001676, A7001677, A7001678, A7001679, A7001681, A7001683, A7001684, A7001685, A7001686, A7001687, A7001688, A7001689, A7001690, A7001691, A7001692, A7001693, A7001694, A7001695, A7001697, A7001698, A7001699, A7001700, A7001701, A7001702, A7001703, A7001704, A7001705, A7001706, A7001707, A7001708, A7001709, A7001710, A7001711, A7001712, A7001713, A7001714, A7001715, A7001716, A7001717, A7001718, A7001719, A7001721, A7001722, A7001723, A7001724, A7001725, A7001726, A7001727, A7001729, A7001730, A7001732, A7001733, A7001734, A7001735, A7001736, A7001737, A7001738, A7001739, A7001740, A7001741, A7001742, A7001743, A7001744, A7001745, A7001746, A7001747, A7001748, A7001749, A7001752, A7001753, A7001754, A7001755, A7001756, A7001757, A7001758, A7001759, A7001760, A7001761, A7001762, A7001763, A7001765, A7001766, A7001767, A7001768, A7001769, A7001770, A7001771, A7001780, A7001781, A7001782, A7001783, A7001784, A7001785, A7001786, A7001787, A7001788, A7001789, A7001790, A7001791, A7001792, A7001793, A7001794, A7001795, A7001800, A7001801, A7001802, A7001803, A7001804, A7001805, A7001806, A7001807, A7001808, A7001809, A7001810, A7001811, A7001812, A7001813, A7001814, A7001815, A7001816, A7001817, A7001819, A7001820, A7001821, A7001822, A7001823, A7001824, A7001825, A7001826, A7001827, A7001828, A7001836, A7001837, A7001841, A7001842, A7001843, A7001844, A7001845, A7001846, A7001847, A7001848, A7001857, A7001858, A7001859, A7001860, A7001861, A7001862, A7001863, A7001864, A7001865, A7001866, A7001867, A7001868, A7001869, A7001870, A7001871, A7001872, A7001873, A7001874, A7001876, A7001877, A7001878, A7001879, A7001880, A7001881, A7001882, A7001883, A7001884, A7001885, A7001886, A7001887, A7001888, A7001889, A7001890, A7001891, A7001892, A7001893, A7001894, A7001895, A7001897, A7001898, A7001899, A7001900, A7001901, A7001902, A7001903, A7001904, A7001905, A7001906, A7001907, A7001908, A7001909, A7001910, A7001911, A7001912, A7001913, A7001914, A7001915, A7001916, A7001917, A7001918, A7001919, A7001920, A7001921, A7001922, A7001923, A7001924, A7001925, A7001927, A7001928, A7001929, A7001930, A7001931, A7001932, A7001933, A7001934, A7001935, A7001936, A7001937, A7001938, A7001939, A7001940, A7001941, A7001942, A7001943, A7001944, A7001945, A7001946, A7001947, A7001948, A7001949, A7001950, A7001951, A7001952, A7001953, A7001954, A7001955, A7001956, A7001957, A7001958, A7001959, A7001960, A7001961, A7001962, A7001963, A7001964, A7001965, A7001966, A7001967, A7001968, A7001969, A7001970, A7001971, A7001972, A7001973, A7001981, A7300000, A7300001, A7300002, A7300003, A7300004, A7300005, A7300006, A7300007, A7300008, A7300012, B6001016, B6001020, B6001023, B6001024, B6001025, B6001026, B6001030, B6001040, B6001041, B6001043, B6001047, B6001049, B6001060, B6001065, B6001066, B6001068, B6001069, B6001070, B6001071, B6001073, B6001080, B6001082, B6001084, B6001085, B6001086, B6001088, B6001090, B6001092, B6001093, B6001094, B6001095, B6001096, B6001097, B6001098, B6001100, B6001102, B6001103, B6001104, B6001107, B6001108, B6001109, B6001110, B6001111, B6001112, B6001113, B6001123, B6001124, B6001130, B6001131, B6001133, B6001138, B6001140, B6001141, B6001143, B6001148, B6001157, B6001160, B6001164, B6001165, B6001166, B6001167, B6001168, B6001169, B6001170, B6001171, B6001172, B6001173, B6001174, B6001175, B6001176, B6001177, B6001178, B6001179, B6001180, B6001181, B6001183, B6001184, B6001185, B6001186, B6001187, B6001198, B6001199, B6001202, B6001203, B6001204, B6001205, B6001206, B6001207, B6001208, B6001209, B6001212, B6001213, B6001216, B6001217, B6001218, B6001219, B6001220, B6001221, B6001223, B6001225, B6001227, B6001231, B6001232, B6001234, B6001237, B6001238, B6001239, B6001241, B6001242, B6001243, B6001244, B6001245, B6001246, B6001254, B6001256, B6001257, B6001258, B6001259, B6001260, B6001261, B6001263, B6001265, B6001267, B6001269, B6001270, B6001271, B6001272, B6001273, B6001276, B6001277, B6001278, B6001279, B6001280, B6001281, B6001282, B6001283, B6001284, B6001285, B6001286, B6001287, B6001288, B6001298, B6001299, 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, B6001339, B6001341, B6001342, B6001343, B6001345, B6001346, B6001348, B6001349, B6001350, B6001351, B6001354, B6001355, B6001356, B6001357, B6001358, B6001359, B6001360, B6001361, B6001362, B6001363, B6001364, B6001365, B6001366, B6001367, B6001369, B6001370, B6001372, B6001373, B6001374, B6001375, B6001377, B6001378, B6001379, B6001381, B6001382, B6001384, B6001386, B6001387, B6001388, B6001389, B6001390, B6001396, B6001397, B6001398, B6001399, B6001401, B6001402, B6001404, B6001406, B6001407, B6001408, B6001409, B6001410, B6001411, B6001419, B6001420, B6001421, B6001422, B6001423, B6001424, B6001425, B6001426, B6001427, B6001428, B6001429, B6001431, B6001435, B6001436, B6001437, B6001438, B6001439, B6001440, B6001441, B6001442, B6001443, B6001444, B6001445, B6001448, B6001449, B6001450, B6001451, B6001452, B6001453, B6001455, B6001456, B6001457, B6001459, B6001461, B6001462, B6001467, B6001468, B6001469, B6001470, B6001471, B6001472, B6001473, B6001474, B6001477, B6001478, B6001479, B6001480, B6001481, B6001482, B6001483, B6001484, B6001485, B6001486, B6001487, B6001488, B6001489, B6001490, B6001491, B6001492, B6001493, B6001494, B6001495, B6001496, B6001497, B6001498, B6001499, B6001500, B6001501, B6001502, B6001503, B6001504, B6001505, B6001506, B6001507, B6001508, B6001509, B6001510, B6001511, B6001512, B6001514, B6001515, B6001516, B6001518, B6001519, B6001520, B6001521, B6001522, B6001523, B6001524, B6001525, B6001526, B6001529, B6001530, B6001531, B6001532, B6001533, B6001535, B6001537, B6001541, B6001542, B6001544, B6001545, B6001546, B6001547, B6001549, B6001550, B6001553, B6001554, B6001557, B6001558, B6001559, B6001560, B6001561, B6001562, B6001563, B6001564, B6001565, B6001567, B6001568, B6001569, B6001570, B6001571, B6001572, B6001573, B6001574, B6001575, B6001576, B6001577, B6001578, B6001579, B6001580, B6001581, B6001582, B6001583, B6001584, B6001585, B6001586, B6001587, B6001588, B6001589, B6001590, B6001591, B6001592, B6001593, B6001594, B6001595, B6001596, B6001597, B6001598, B6001599, B6001600, B6001601, B6001602, B6001603, B6001604, B6001605, B6001606, B6001608, B6001609, B6001610, B6001611, B6001612, B6001613, B6001614, B6001615, B6001616, B6001617, B6001618, B6001619, B6001620, B6001621, B6001622, B6001623, B6001624, B6001627, B6001628, B6001629, B6001630, B6001631, B6001632, B6001633, B6001634, B6001635, B6001636, B6001637, B6001638, B6001639, B6001640, B6001641, B6001642, B6001643, B6001644, B6001645, B6001646, B6001647, B6001648, B6001660, B6001661, B6001662, B6001663, B6001664, B6001665, B6001666, B6001667, B6001668, B6001669, B6001670, B6001672, B6001673, B6001674, B6001675, B6001676, B6001677, B6001678, B6001679, B6001680, B6001681, B6001682, B6001683, B6001685, B6001686, B6001687, B6001688, B6001689, B6001691, B6001692, B6001693, B6001694, B6001695, B6001696, B6001697, B6001698, B6001699, B6001700, B6001701, B6001702, B6001703, B6001704, B6001705, B6001707, B6001708, B6001709, B6001710, B6001711, B6001712, B6001713, B6001715, B6001716, B6001717, B6001718, B6001719, B6001720, B6001721, B6001722, B6001723, B6001724, B6001725, B6001726, B6001727, B6001728, B6001729, B6001730, B6001731, B6001733, B6001734, B6001735, B6001736, B6001738, B6001739, B6001740, B6001741, B6001742, B6001743, B6001744, B6001746, B6001747, B6001748, B6001750, B6001751, B6001752, B6001753, B6001754, B6001755, B6001756, B6001757, B6001758, B6001759, B6001761, B6001762, B6001764, B6001765, B6001766, B6001767, B6001768, B6001769, B6001770, B6001771, B6001772, B6001773, B6001774, B6001776, B6001777, B6001778, B6001779, B6001780, B6001781, B6001782, B6001783, B6001787, B6001788, B6001790, B6001791, B6001793, B6001795, B6001796, B6001797, B6001798, B6001799, B6001800, B6001801, B6001803, B6001805, B6001806, B6001807, B6001808, B6001809, B6001810, B6001811, B6001812, B6001813, B6001814, B6001815, B6001816, B6001817, B6001818, B6001819, B6001820, B6001821, B6001822, B6001824, B6001825, B6001826, B6001827, B6001828, B6001829, B6001830, B6001831, B6001832, B6001833, B6001834, B6001835, B6001836, B6001838, B6001839, B6001840, B6001841, B6001842, B6001843, B6001844, B6001845, B6001846, B6001848, B6001849, B6001850, B6001851, B6001852, B6001853, B6001854, B6001855, B6001856, B6001857, B6001858, B6001859, B6001860, B6001861, B6001862, B6001863, B6001864, B6001865, B6001866, B6001867, B6001868, B6001869, B6001870, B6001871, B6001872, B6001873, B6001874, B6001875, B6001876, B6001877, B6001878, B6001879, B6001880, B6001881, B6001882, B6001883, B6001884, B6001885, B6001887, B6001888, B6001889, B6001890, B6001891, B6001892, B6001893, B6001894, B6001895, B6001896, B6001897, B6001898, B6001899, B6001900, B6001901, B6001902, B6001903, B6001904, B6001905, B6001906, B6001907, B6001908, B6001909, B6001910, B6001911, B6001912, B6001913, B6001914, B6001915, B6001916, B6001917, B6001918, B6001919, B6001920, B6001921, B6001922, B6001923, B6001924, B6001925, B6001926, B6001927, B6001928, B6001930, B6001931, B6001932, B6001934, B6001935, B6001936, B6001937, B6001938, B6001939, B6001940, B6001941, B6001942, B6001943, B6001944, B6001945, B6001946, B6001947, B6001948, B6001949, B6001950, B6001951, B6001952, B6001953, B6001954, B6001955, B6001956, B6001957, B6001958, B6001959, B6001960, B6001961, B6001962, B6001963, B6001964, B6001965, B6001966, B6001967, B6001968, B6001969, B6001972, B6001973, B6001974, B6001975, B6001976, B6001977, B6001978, B6001979, B6001980, B6001981, B6001982, B6001983, B6001984, B6001986, B6001987, B6001988, B6001989, B6001990, B6001991, B6001992, B6001993, B6001994, B6001995, B6001996, B6001997, B6001998, B6001999, B6002000, B6002001, B6002002, B6002003, B6002004, B6002005, B6002007, B6002008, B6002009, B6002010, B6002011, B6002012, B6002013, B6002014, B6002015, B6002016, B6002017, B6002018, B6002019, B6002020, B6002021, B6002022, B6002023, B6002024, B6002025, B6002026, B6002027, B6002028, B6002029, B6002030, B6002031, B6002032, B6002033, B6002034, B6002035, B6002036, B6002037, B6002038, B6002039, B6002040, B6002041, B6002042, B6002043, B6002044, B6002045, B6002047, B6002048, B6002049, B6002050, B6002051, B6002052, B6002054, B6002055, B6002057, B6002058, B6002059, B6002060, B6002061, B6002062, B6002063, B6002064, B6002065, B6002066, B6002067, B6002068, B6002069, B6002070, B6002071, B6002072, B6002073, B6002074, B6002075, B6002076, B6002077, B6002078, B6002079, B6002080, B6002081, B6002082, B6002083, B6002084, B6002085, B6002086, B6002087, B6002088, B6002089, B6002090, B6002091, B6002092, B6002093, B6002094, B6002096, B6002097, B6002098, B6002099, B6002100, B6002101, B6002102, B6002103, B6002104, B6002105, B6002106, B6002107, B6002108, B6002109, B6002110, B6002111, B6002112, B6002113, B6002114, B6002115, B6002116, B6002117, B6002118, B6002119, B6002120, B6002121, B6002122, B6002123, B6002124, B6002125, B6002126, B6002127, B6002128, B6002129, B6002130, B6002131, B6002132, B6002133, B6002134, B6002135, B6002136, B6002137, B6002138, B6002139, B6002140, B6002141, B6002142, B6002143, B6002145, B6002147, B6002148, B6002149, B6002150, B6002151, B6002152, B6002153, B6002154, B6002155, B6002156, B6002157, B6002158, B6002159, B6002160, B6002161, B6002162, B6002163, B6002164, B6002168, B6002169, B6002170, B6002171, B6002172, B6002173, B6002174, B6002175, B6002176, B6002177, B6002178, B6002179, B6002180, B6002181, B6002182, B6002183, B6002184, B6002185, B6002186, B6002187, B6002188, B6002189, B6002190, B6002191, B6002192, B6002193, B6002195, B6002196, B6002197, B6002198, B6002199, B6002200, B6002201, B6002202, B6002203, B6002204, B6002205, B6002206, B6002207, B6002208, B6002209, B6002210, B6002211, B6002212, B6002213, B6002214, B6002215, B6002216, B6002217, B6002218, B6002219, B6002220, B6002221, B6002222, B6002223, B6002224, B6002225, B6002226, B6002227, B6002228, B6002229, B6002230, B6002231, B6002232, B6002233, B6002234, B6002235, B6002236, B6002237, B6002238, B6002239, B6002240, B6002241, B6002242, B6002243, B6002244, B6002245, B6002246, B6002247, B6002248, B6002251, B6002252, B6002253, B6002254, B6002255, B6002256, B6002257, B6002258, B6002259, B6002260, B6002261, B6002262, B6002263, B6002264, B6002265, B6002266, B6002267, B6002268, B6002269, B6002270, B6002271, B6002272, B6002273, B6002274, B6002275, B6002276, B6002277, B6002278, B6002279, B6002280, B6002281, B6002282, B6002283, B6002284, B6002285, B6002286, B6002287, B6002288, B6002289, B6002292, B6002293, B6002294, B6002295, B6002296, B6002297, B6002298, B6002299, B6002300, B6002301, B6002302, B6002303, B6002304, B6002305, B6002306, B6002307, B6002308, B6002309, B6002310, B6002311, B6002313, B6002314, B6002315, B6002316, B6002317, B6002318, B6002319, B6002320, B6002321, B6002322, B6002323, B6002324, B6002325, B6002326, B6002327, B6002328, B6002329, B6002331, B6002332, B6002334, B6002335, B6002336, B6002337, B6002338, B6002339, B6002340, B6002341, B6002342, B6002343, B6002345, B6002346, B6002347, B6002348, B6002349, B6002350, B6002351, B6002352, B6002353, B6002354, B6002356, B6002357, B6002358, B6002359, B6002360, B6002361, B6002362, B6002363, B6002364, B6002365, B6002366, B6002367, B6002368, B6002369, B6002370, B6002371, B6002373, B6002374, B6002375, B6002376, B6002377, B6002378, B6002379, B6002381, B6002382, B6002383, B6002384, B6002385, B6002386, B6002387, B6002388, B6002389, B6002390, B6002391, B6002392, B6002393, B6002394, B6002395, B6002396, B6002398, B6002399, B6002401, B6002402, B6002403, B6002404, B6002405, B6002406, B6002407, B6002408, B6002411, B6002412, B6002413, B6002414, B6002415, B6002416, B6002417, B6002418, B6002419, B6002420, B6002421, B6002422, B6002423, B6002424, B6002425, B6002426, B6002427, B6002428, B6002429, B6002430, B6002431, B6002432, B6002433, B6002434, B6002435, B6002436, B6002437, B6002438, B6002439, B6002440, B6002441, B6002442, B6002443, B6002444, B6002445, B6002446, B6002447, B6002448, B6002449, B6002451, B6002452, B6002457, B6002458, B6002459, B6002460, B6002461, B6002462, B6002463, B6002469, B6002470, B6002471, B6002472, B6002473, B6002474, B6002475, B6002476, B6002477, B6002478, B6002479, B6002480, B6002481, B6002482, B6002483, B6002484, B6002485, B6002486, B6002487, B6002488, B6002489, B6002490, B6002491, B6002492, B6002493, B6002494, B6002495, B6002496, B6002504, B6002505, B6002506, B6002507, B6002508, B6002509, B6002510, B6002511, B6002512, B6002513, B6002514, B6002515, B6002519, B6002520, B6002521, B6002522, B6002524, B6002525, B6002526, B6002528, B6002529, B6002530, B6002531, B6002534, B6002535, B6002536, B6002542, B6002543, B6002544, B6002545, B6002546, B6002547, B6002548, B6002549, B6002550, B6002551, B6002553, B6002554, B6002555, B6002556, B6002557, B6002558, B6002559, B6002560, B6002561, B6002562, B6002563, B6002564, B6002565, B6002566, B6002602, B6002667, B6002668, B6002669, B6002670, B6002671, B6002672, B6002673, B6002674, B6002675, B6002676, B6002677, B6002678, B6002679, B6002680, B6002681, B6002682, B6002683, B6002684, B6002685, B6002686, B6002687, B6002688, B6002689, B6002690, B6002691, B6002692, B6002693, B6002694, B6002695, B6002696, B6002697, B6002698, B6002700, B6002701, B6002702, B6002703, B6002704, B6002705, B6002707, B6002708, B6002709, B6002710, B6002711, B6002712, B6002713, B6002714, B6002715, B6002716, B6002717, B6002718, B6002719, B6002720, B6002722, B6002723, B6002724, B6002725, B6002726, B6002727, B6002728, B6002729, B6002730, B6002732, B6002733, B6002734, B6002735, B6002736, B6002737, B6002746, B6002747, B6002748, B6002749, B6002750, B6002751, B6002752, B6002753, B6002754, B6002755, B6002756, B6002757, B6002758, B6002759, B6002760, B6002761, B6002762, B6002763, B6002764, B6002765, B6002766, B6002767, B6002768, B6002769, B6002770, B6002771, B6002772, B6002773, B6002774, B6002775, B6002777, B6002778, B6002779, B6002781, B6002782, B6002783, B6002784, B6002785, B6002786, B6002787, B6002788, B6002789, B6002790, B6002791, B6002792, B6002793, B6002794, B6002795, B6002796, B6002797, B6002798, B6002799, B6002800, B6002801, B6002803, B6002805, B6002806, B6002807, B6002808, B6002809, B6002810, B6002811, B6002812, B6002813, B6002815, B6002816, B6002817, B6002818, B6002819, B6002820, B6002821, B6002822, B6002823, B6002824, B6002825, B6002826, B6002827, B6002828, B6002829, B6002830, B6002831, B6002832, B6002833, B6002834, B6002835, B6002836, B6002837, B6002838, B6002839, B6002840, B6002841, B6002842, B6002843, B6002844, B6002845, B6002849, B6002857, B6002858, B6002859, B6002860, B6002861, B6002862, B6002863, B6002864, B6002865, B6002866, B6002867, B6002868, B6002869, B6002870, B6002871, B6002872, B6002873, B6002874, B6002875, B6002876, B6002878, B6002879, B6002880, B6002881, B6002882, B6002883, B6002884, B6002885, B6002886, B6002888, B6002889, B6002890, B6002891, and B6002892. ****SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE THE USA***** 00001001, 00001007, 00001008, A7001048, A7001069, A7001071, A7001089, A7001090, A7001091, A7001092, A7001095, A7001096, A7001097, A7001100, A7001102, A7001103, A7001106, A7001107, A7001108, A7001109, A7001110, A7001111, A7001112, A7001113, A7001114, A7001115, A7001133, A7001136, A7001263, A7001280, A7001282, A7001442, A7001443, A7001444, A7001720, A7001796, A7001797, A7001798, A7001799, A7001829, A7001830, A7001831, A7001832, A7001833, A7001834, A7001835, A7001838, A7001839, A7001840, A7001849, A7001850, A7001851, A7001852, A7001853, A7001854, A7001855, A7001856, B6001063, B6001064, B6001075, B6001079, B6001081, B6001188, B6001189, B6001211, B6001224, B6001233, B6001251, B6001289, B6001294, B6001296, B6001300, B6001337, B6001347, B6001353, B6001368, B6001371, B6001380, B6001383, B6001391, B6001393, B6001394, B6001395, B6001405, B6001412, B6001413, B6001416, B6001418, B6001432, B6001446, B6001447, B6001454, B6001465, B6001466, B6001475, B6001476, B6001517, B6001534, B6001539, B6001540, B6001548, B6001551, B6001552, B6001556, B6001607, B6001625, B6001671, B6001684, B6001690, B6001714, B6001732, B6001745, B6001749, B6001760, B6001763, B6001775, B6001784, B6001785, B6001786, B6001789, B6001792, B6001802, B6001847, B6001886, B6001929, B6001933, B6001970, B6001971, B6001985, B6002053, B6002056, B6002166, B6002167, B6002194, B6002250, B6002290, B6002291, B6002330, B6002333, B6002344, B6002372, B6002409, B6002410, B6002450, B6002453, B6002454, B6002455, B6002456, B6002523, B6002532, B6002533, B6002552, B6002567, B6002568, B6002569, B6002570, B6002571, B6002572, B6002573, B6002574, B6002575, B6002576, B6002577, B6002578, B6002579, B6002580, B6002581, B6002582, B6002583, B6002584, B6002585, B6002586, B6002587, B6002588, B6002589, B6002590, B6002591, B6002592, B6002593, B6002594, B6002595, B6002596, B6002597, B6002598, B6002599, B6002600, B6002601, B6002603, B6002604, B6002605, B6002606, B6002607, B6002608, B6002609, B6002610, B6002611, B6002612, B6002613, B6002614, B6002615, B6002616, B6002617, B6002618, B6002619, B6002620, B6002621, B6002622, B6002623, B6002624, B6002625, B6002626, B6002627, B6002628, B6002629, B6002630, B6002631, B6002632, B6002633, B6002634, B6002635, B6002636, B6002637, B6002638, B6002639, B6002640, B6002641, B6002642, B6002643, B6002644, B6002645, B6002646, B6002647, B6002648, B6002649, B6002650, B6002651, B6002652, B6002653, B6002654, B6002655, B6002656, B6002657, B6002658, B6002659, B6002660, B6002661, B6002662, B6002663, B6002664, B6002665, B6002666, B6002706, B6002731, B6002738, B6002739, B6002740, B6002741, B6002742, B6002743, B6002744, B6002802, B6002804, and B6002877.
• Recalling Firm/ Manufacturer: Verathon, Inc.; 20001 N Creek Pkwy; Bothell WA 98011-8218
• For Additional Information Contact: Verathon Customer Care ; 866-875-0382
• Manufacturer Reason for Recall: The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).
• FDA Determined Cause: Device Design
• Action: Verathon sent an URGENT: MEDICAL DEVICE CORRECTION BLADDERSCAN BVI 9600 WITH AORTASCAN MODE & AORTASCAN AMI 9700 letter dated November 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Verathon will manage other international consignees outside Europe internally and follow a similar approach as the firm requested Stericycle to perform. Verathon will instruct the companys foreign distributors to communicate the Customer Correction Letter and provide the revised OMMs to their international customers. This current Medical Device Correction is intended to reinforce the message in the May 2014 communication regarding the potential variance in measurement and to provide you with updated Operation and Maintenance Manuals that further reinforce the devices intended use and indications for use and that revise warning information, including warnings specified in the May 2014 communication. Customers are instructed to destroy all existing Operations and Maintenance Manuals and replace them with updated versions and complete the information on the Medical Device Correction Reply Form and fax or email the completed form within 10 business days to: Fax: (877) 907-9956 or Email: verathon3108@stericycle.com. Customers with any questions can contact your Verathon representative or Verathon Customer Care at (866) 875-0382. Verathon has live agent support on Monday through Friday from 8am to 5 pm Pacific Time. Customers should report any suspected malfunction or adverse event related to any AortaScan AMI 9700 devices and any BladderScan BVI 9600 devices to Verathon Customer Care at (800) 331-2313
• Quantity in Commerce: 2524 units total (1441 units of BVI 9600 and 820 units of AMI 9700 in US; 209 units of BVI 9600 and 54 units of AMI 9700 OUTSIDE the US
• Distribution: Worldwide Distribution - US (nationwide) and to the countries of : Guam, United Arab Emirates, Australia, Belgium, Canada , China, Czech Republic, France, Germany, Luxembourg, Netherlands, Norway, Saudi Arabia, Sweden , Taiwan, and United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYO