Events

Retiro De Equipo (Recall) de Device Recall Esaote PA230E Transducer

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Biosound Esaote, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68648
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2167-2014
  • Fecha de inicio del evento
    2014-06-26
  • Fecha de publicación del evento
    2014-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128485
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Transducer Ultrasonic - Product Code JOP
  • Causa
    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.
  • Acción
    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
  • Modelo / 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.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    Esaote PA230E Transducer || A portable and cart base ultrasound system for general and cardiovascular imaging
  • Manufacturer
    Biosound Esaote, Inc.

Manufacturer

Biosound Esaote, Inc.
  • Dirección del fabricante
    Biosound Esaote, Inc., 8000 Castleway Dr, Indianapolis IN 46250-1943
  • Source
    USFDA