Events

Recall of Device Recall Esaote PA230E Transducer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosound Esaote, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68648
  • Event Risk Class
    Class 2
  • Event Number
    Z-2167-2014
  • Event Initiated Date
    2014-06-26
  • Event Date Posted
    2014-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128485
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Transducer Ultrasonic - Product Code JOP
  • 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.
  • 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

Device

Device Recall Esaote PA230E Transducer
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    Esaote PA230E Transducer || A portable and cart base ultrasound system for general and cardiovascular imaging
  • Manufacturer
    Biosound Esaote, Inc.

Manufacturer

Biosound Esaote, Inc.
  • Manufacturer Address
    Biosound Esaote, Inc., 8000 Castleway Dr, Indianapolis IN 46250-1943
  • Source
    USFDA