Device Recall Esaote PA230E Transducer

  • Modèle / numéro de série
    Part #: 9600165000 PROBE, PA230E Serial #'s: 07011, 10005, 10007, 10010, 10011, 10012, 10013, 10015, 10017, 10021, 10042, 10068, 10070, 10079, 10085, 10086, 10087, 10088, 10089, 10092, 10101, 10102, 10117, 10139, 10149, 10154, 10155, 10169, 10170, 10176, 10177, 10179, 10183, 10184, 10194, 10203, 10205, 10217, 10238, 10246, 10247, 10284, 10285, 10286, 10294, 10300, 10301, 10303, 10305, 10306, 10313, 10314, 10318, 10482, 10533, 10534, 10539, 10548, 10559, 10560, 106, 10729, 10820, 10905, 10906, 10907, 10908, 10909, 10984, 1100, 11011, 11032, 11108, 11124, 11126, 11138, 11168, 11171, 11179, 11184, 11188, 11198, 11199, 11206, 11215, 11226, 11326, 11327, 11332, 11353, 11374, 1142, 1152, 1154, 1161, 1163, 1170, 11794, 11809, 11987, 12003, 12006, 12018, 12028, 12059, 12060, 12062, 12063, 12064, 12065, 12073, 12126, 12127, 12133, 12137, 12138, 12141, 12143, 12144, 12150, 12151, 12153, 12158, 12161, 12174, 12178, 12180, 12183, 12184, 12186, 12192, 12193, 1220, 12200, 12202, 12203, 12205, 12216, 12217, 12312, 12321, 12327, 12332, 12335, 1235, 12353, 12355, 12356, 12384, 12627, 12632, 12812, 12912, 1300, 13019, 13025, 13046, 13051, 13073, 13074, 13075, 13082, 13129, 13146, 13168, 13179, 13180, 13186, 13255, 13258, 13260, 13265, 13268, 13271, 13274, 13275, 13277, 13288, 13289, 13290, 13292, 13323, 13325, 13326, 13437, 13524, 13540, 13567, 13588, 13590, 13593, 13629, 139, 14083, 14085, 14088, 14203, 14204, 14317, 14318, 14319, 14328, 14329, 14331, 14333, 14347, 14541, 14545, 14547, 14548, 14784, 148, 14827, 14875, 14894, 14895, 14921, 14926, 14927, 14929, 14949, 14950, 14951, 14952, 14953, 14954, 14955, 14956, 14970, 14977, 14978, 15242, 15243, 15244, 15247, 15289, 15291, 15293, 15307, 15308, 15310, 15311, 15315, 1543, 15631, 15632, 15646, 15648, 15649, 15650, 15654, 15656, 15711, 15712, 15714, 15716, 15949, 1595, 15951, 15954, 15955, 15957, 15958, 15959, 1596, 15960, 15961, 15962, 1600, 16004, 16005, 16008, 16009, 16010, 16011, 16013, 16015, 16019, 16022, 16023, 1603, 164, 16410, 16474, 16475, 16477, 16478, 16556, 16712, 16714, 16715, 16716, 16718, 1672, 16720, 16732, 16766, 16767, 16768, 16769, 1677, 16770, 16771, 16772, 16774, 16775, 16776, 16777, 16779, 16780, 16791, 16959, 16960, 16962, 16965, 16966, 16967, 16968, 16969, 1697, 16970, 16972, 16974, 16975, 17137, 17138, 17139, 17140, 17141, 17144, 17145, 17148, 17149, 17150, 17151, 17153, 17154, 17309, 17310, 17312, 17313, 17318, 17319, 17320, 17321, 17323, 17324, 1806, 182, 1830, 1832, 1835, 18421, 18508, 18522, 18524, 18525, 18526, 18590, 18591, 18594, 1864, 1867, 18700, 18773, 18776, 1882, 18836, 18837, 18840, 18854, 18872, 18932, 18935, 19236, 19237, 19273, 19275, 19276, 19482, 19496, 19558, 19561, 19564, 19580, 19585, 19604, 19770, 2 left, 2000, 2004, 2005, 20114, 20117, 20127, 20128, 20131, 20132, 20133, 20141, 20150, 20151, 20152, 20154, 20155, 20179, 20180, 20182, 20184, 20185, 20187, 20255, 20256, 20257, 20258, 20259, 20260, 20261, 20262, 20263, 20264, 20267, 20277, 20278, 20280, 20282, 20283, 20284, 20287, 20367, 20425, 20437, 20455, 20467, 20469, 20470, 20471, 20472, 20473, 20484, 20504, 20508, 20509, 20515, 20517, 20519, 20520, 20521, 20522, 20523, 20524, 20525, 20526, 20605, 20606, 20607, 20608, 20627, 20634, 20967, 21025, 21026, 21027, 21029, 2103, 21030, 21031, 21032, 21033, 2104, 21047, 21103, 21104, 21105, 21106, 21107, 21108, 21109, 21110, 21111, 21113, 21114, 21115, 21117, 21118, 21121, 21125, 21126, 2114, 21146, 21149, 21151, 21171, 21180, 21183, 21184, 21192, 21193, 21194, 21196, 21197, 21198, 21199, 212, 21200, 21201, 21284, 21285, 21286, 21287, 21289, 21291, 21292, 21294, 21297, 21298, 21300, 21301, 21302, 21303, 21304, 21585, 21586, 21588, 21589, 21739, 21740, 21741, 21753, 21754, 21755, 21756, 21757, 21758, 21759, 21760, 21761, 21762, 2183, 21836, 21838, 21839, 21840, 21841, 21842, 2185, 2186, 2210, 22258, 22259, 22260, 22261, 22262, 22263, 22264, 22265, 22266, 22268, 22269, 22270, 22271, 22272, 22273, 22274, 22275, 22276, 22277, 22408, 22460, 22465, 22469, 2247, 22470, 22471, 22475, 22477, 22481, 22483, 22488, 22489, 22490, 2255, 2268, 22738, 22739, 22740, 22741, 22742, 22823, 22824, 22825, 22826, 22828, 22872, 22873, 22875, 22876, 22878, 22880, 22890, 22939, 22945, 22956, 23014, 23015, 23043, 23044, 23048, 23049, 23050, 23089, 2323, 2377, 2418, 2419, 2424, 2426, 2431, 2433, 2445, 2469, 2491, 2493, 2494, 2504, 2517, 2518, 2523, 2532, 2536, 254, 2549, 2595, 2599, 2602, 2606, 263, 2985, 3030, 3031, 3055, 3056, 3119, 3121, 3126, 3139, 3236, 3241, 3360, 3365, 3484, 3508, 3509, 3510, 3515, 3534, 3535, 3536, 3540, 3587, 3588, 3593, 3608, 3636, 3640, 3642, 3645, 3651, 3653, 3691, 374, 3743, 375, 3750, 3751, 3754, 3762, 3765, 3773, 3776, 3777, 3778, 3779, 3789, 3790, 3802, 3804, 3806, 3811, 3813, 3814, 3817, 3832, 3844, 3846, 3848, 3895, 3896, 3897, 3899, 3900, 3925, 3926, 3927, 3928, 3930, 3931, 3933, 3935, 3936, 3937, 3938, 3940, 3942, 3948, 3951, 3964, 3998, 4021, 4022, 4045, 410, 4185, 4186, 4188, 4193, 4203, 4253, 4260, 4264, 4265, 4275, 4298, 4302, 4313, 4314, 4319, 4338, 4344, 4347, 4375, 4412, 4417, 4420, 4422, 4479, 4480, 4483, 4486, 4498, 4502, 4505, 4521, 4560, 4564, 4596, 4616, 4619, 4621, 4632, 4635, 4683, 469, 4704, 4707, 4710, 4808, 4809, 4812, 4821, 4822, 4904, 4907, 4938, 4939, 4940, 4942, 4944, 4947, 4948, 4975, 4979, 4980, 4981, 4982, 4990, 5062, 5063, 5068, 5069, 5075, 5076, 5078, 5082, 5089, 5147, 5159, 5187, 5191, 5192, 5194, 5196, 5201, 5208, 5209, 5210, 5219, 5221, 5223, 5226, 5233, 5234, 5235, 5236, 5239, 5242, 5250, 5274, 5277, 5280, 5311, 533, 5338, 5339, 5340, 5341, 5345, 5397, 5401, 5419, 5428, 5429, 5431, 5432, 5433, 5446, 5447, 5450, 5451, 5460, 5497, 5498, 550, 5528, 557, 5572, 5573, 5574, 5576, 5577, 5578, 5579, 5584, 5587, 5612, 5686, 5688, 5715, 5778, 5780, 5782, 5783, 5785, 5826, 5827, 5829, 5832, 5834, 5840, 5841, 5843, 5844, 5846, 5872, 5886, 5894, 5905, 5912, 5917, 5922, 5935, 5957, 5999, 6109, 613, 6133, 6135, 6137, 6141, 615, 6198, 6202, 6203, 6204, 6215, 6216, 623, 6232, 6239, 6247, 6255, 6264, 6265, 6270, 6271, 6273, 6274, 6275, 6287, 6289, 6292, 6293, 6303, 6310, 6320, 6358, 6397, 641, 6416, 6419, 662, 6688, 6714, 6723, 6726, 6728, 6767, 6799, 6800, 6802, 6886, 6906, 6907, 6909, 6912, 6916, 6945, 6947, 6948, 6951, 6952, 6953, 6960, 6967, 6969, 6970, 6972, 6973, 6974, 6980, 6981, 6983, 7013, 7014, 7015, 7033, 7035, 7048, 7064, 7065, 7108, 7109, 7111, 7114, 7117, 7120, 7124, 7129, 7131, 714, 7141, 7151, 7152, 7159, 7160, 7179, 7182, 7184, 7185, 7188, 7189, 7190, 7191, 7192, 7194, 720, 7205, 7216, 722, 7245, 7264, 7265, 7266, 7302, 7303, 7305, 7318, 7325, 7331, 7338, 7339, 7342, 7343, 7357, 7361, 7366, 7372, 7386, 7388, 7389, 7390, 7429, 7447, 7452, 7454, 7483, 7501, 7504, 7527, 7536, 7539, 7541, 7542, 7545, 7546, 7554, 7555, 7565, 7570, 7572, 7573, 7577, 7578, 7615, 7617, 7629, 7862, 7914, 7915, 7916, 7917, 7918, 7919, 7921, 7922, 7923, 7924, 7925, 7928, 7931, 7932, 7933, 8198, 827, 8332, 8333, 8334, 8336, 8339, 834, 8340, 8345, 8346, 8396, 8436, 8443, 8496, 8498, 8507, 8508, 8510, 8511, 8514, 8515, 8516, 8529, 853, 8541, 8545, 8550, 862, 8836, 884, 890, 8956, 9003, 9022, 9054, 9058, 9063, 9076, 9079, 9083, 9085, 9112, 9178, 9185, 9191, 9193, 9194, 9209, 9240, 9244, 9250, 9266, 9267, 9271, 9272, 9273, 9274, 9278, 9279, 9282, 9286, 9289, 9290, 9291, 9394, 9398, 9401, 9404, 9405, 9406, 9409, 9415, 9419, 9424, 9426, 944, 9468, 9480, 9483, 9484, 9485, 9486, 9487, 9495, 9505, 9515, 96, 9600165000S, 9683, 97, 979, 9824, 983, 9836, 9874, 9889, 9890, 9912, 9934, 9935, 9943, 9944, 9945, 9956, 9957, 9969, 9972, 9975, 9992, 9994 & 9997.   Part #: 97154411675 PROBE, PA230E Serial #'s: 13373, 13550, 13754, 13764, 13767, 13776, 13778, 13790, 13803, 13836, 13842, 13856, 13965, 13996, 14006, 14018, 14710, 14982, 15001, 15005, 15021, 15022, 15033, 15037, 15039, 15059, 15166, 15179, 15181, 15184, 15185, 15483, 15484, 15670, 15731, 15751, 16689, 16694, 16798, 16799, 16807, 16816, 16817, 16819, 18024, 18037, 18059, 18085, 18089, 18635, 18653, 18654, 18656, 18657, 18659, 18667, 18677, 18943, 18944, 18948, 18949, 18950, 18953, 18956, 18959, 18960, 18962, 18963, 18965, 18991, 18996, 18997, 19008, 19012, 19017, 19019, 19250, 19251, 19252, 19253, 19255, 19256, 19259, 19260, 19261, 19262, 19263, 19295, 19520, 19522, 19530, 19531, 19714, 19734, 19739, 19904, 19914, 19921, 19926, 19931, 19933, 19998, 20493, 20494, 20529, 20550, 20555, 20557, 20566, 20568, 20570, 20573, 20575, 20576, 20585, 20588, 20589, 20787, 20851, 20854, 20874, 20883, 20885, 20894, 20900, 20908, 20909, 20933, 20935, 20938, 20941 & 20948.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide-Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV. International**Product was also shipped to consignees in Canada
  • Description du dispositif
    Esaote PA230E Transducer || A portable and cart base ultrasound system for general and cardiovascular imaging
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biosound Esaote, Inc., 8000 Castleway Dr, Indianapolis IN 46250-1943
  • Source
    USFDA