Biosound Esaote, Inc.: Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging

Recall number

Z-2167-2014

Recalling firm

Biosound Esaote, Inc.

Product

Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging

Status

Terminated

Initiated

2014-06-26

Posted

2014-08-08

Terminated

2015-07-17

Reason

Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit.

Root cause

Software design

Action

On 06/26/2014, Esaote North America sent an advisory letter via FEDEX (with signature required) to each customer or consignee affected by this voluntary recall. The packet contained the advisory letter, including actions to be taken by the user, information about a pending software upgrade, and a business reply card to confirm they received the letter and have the equipment noted on the advisory letter. Customers with questions were instructed to call 800-428-7378. For questions regarding this recall call 1-317-813-6005

Quantity

1,301 units

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

Lot, serial or model codes

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.

510(k) numbers

["K040596","K050326","K110688"]

PMA numbers

not on file

Product code

JOP

Firm FEI

1826555

Firm city

Indianapolis

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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