FDAFDA · Alimentos y medicamentos·N.º oficial Z-2167-2014
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Publicado el 20 de agosto de 2014 · Inicio del retiro: 26 de junio de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Biosound Esaote, Inc.
- Distribuidor
- 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
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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