Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

Detalles del retiro

Fabricante

Boston Scientific CRM Corp

Distribuidor

Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Poland, Portugal, Saudi Arabia, Singapore, Si Lanka, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, UK, United Arab Republic, and Venezuela.

Lote

Model N118, Serial numbers: 559191, 559192, 559195, 559196, 559200, 559201, 559202, 559203, 559210, 559211, 559212, 559215, 559222, 559223, 559225, 559226, 559231, 559232, 559236, 559238, 559239, 559240, 559241, 559242, 559245, 559247, 559250, 559251, 559253, 559257, 559260, 559262, 559263, 559266, 559267, 559272, 559273, 559275, 559277, 559278, 559279, 559281, 559282, 559283, 559286, 559289, 559292, 559294, 559298, 559300, 559301, 559303, 559306, 559307, 559314, 559317, 559318, 559319, 559321, 559322, 559324, 559325, 559327, 559330, 559334, 559336, 559338, 559339, 559340, 559341, 559342, 559343, 559344, 559349, 559350, 559353, 559355, 559359, 559361, 559368, 559372, 559373, 559374, 559378, 559379, 559381, 559382, 559384, 559385, 559388, 559389, 559391, 559393, 559394, 559395, 559396, 559397, 559398, 559399, 559400, 559405, 559410, 559412, 559413, 559415, 559416, 559417, 559418, 559419, 559420, 559423, 559426, 559428, 559429, 559431, 559435, 559437, 559438, 559439, 559444, 559446, 559448, 559449, 559451, 559453, 559454, 559457, 559459, 559460, 559462, 559463, 559465, 559466, 559467, 559468, 559469, 559471, 559474, 559475, 559476, 559478, 559483, 559484, 559489, 559491, 559492, 559493, 559496, 559498, 559499, 559503, 559504, 559508, 559512, 559514, 559515, 559519, 559525, 559527, 559528, 559530, 559531, 559534, 559535, 559538, 559539, 559540, 559541, 559547, 559571, 559573, 559575, 559577, 559579, 559580, 559581, 559585, 559586, 559587, 559589, 559617, 559618, 559619, 559621, 559623, 559624, 559626, 559627, 559634, 559647, 559649, 559650, 559653, 559654, 559658, 559659, 559684, 559685, 559686, 559704, 559705, 559706, 559708, 559710, 559715, 559717, 559718, 559719, 559724, 559725, 559726, 559729, 559730, 559732, 559733, 559739, 559741, 559743, 559745, 559747, 559748, 559762, 559763, 559764, 559765, 559769, 559770, 559771, 559773, 559775, 559778, 559781, 559782, 559785, 559788, 559789, 559795, 559801, 559802, 559807, 559809, 559810, 559811, 559812, 559814, 559816, 559818, 559822, 559826, 559828, 559830, 559833, 559836, 559839, 559841, 559842, 559843, 559846, 559848, 559852, 559853, 559855, 559858, 559860, 559862, 559863, 559867, 559868, 559870, 559872, 559873, 559874, 559880, 559881, 559886, 559890, 559891, 559892, 559894, 559896, 559897, 559899, 559900, 559904, 559908, 559909, 559914, 559916, 559917, 559919, 559921, 559926, 559927, 559929, 559932, 559936, 559937, 559939, 559941, 559942, 559943, 559944, 559945, 559946, 559948, 559950, 559951, 562253, 562255, 562256, 562258, 562260, 562262, 562264, 562265, 562267, 562269, 562270, 562271, 562275, 562276, 562278, 562282, 562283, 562284, 562285, 562287, 562289, 562291, 562292, 562293, 562297, 562299, 562303, 562305, 562308, 562309, 562310, 562314, 562315, 562317, 562318, 562319, 562321, 562322, 562323, 562324, 562325, 562326, 562327, 562329, 562330, 562331, 562333, 562339, 562341, 562344, 562345, 562347, 562348, 562349, 562350, 562360, 562361, 562362, 562363, 562364, 562366, 562367, 562373, 562375, 562378, 562379, 562380, 562382, 562383, 562384, 562387, 562429, 562433, 562435, 562437, 562523, 562524, 562525, 562526, 562527, 562528, 562530, 562532, 562533, 562535, 562536, 562538, 562540, 562541, 562543, 562544, 562545, 562548, 562553, 562555, 562558, 562559, 562560, 562563, 562564, 562565, 562568, 562569, 562570, 562572, 562575, 562577, 562579, 562580, 562581, 562583, 562585, 562586, 562587, 562589, 562590, 562595, 562597, 562599, 562601, 562603, 562604, 562606, 562607, 562609, 562611, 562613, 562614, 562616, 562618, 562619, 562620, 562621, 562624, 562625, 562626, 562627, 562628, 562631, 562632, 562633, 562634, 562635, 562640, 562643, 562644, 562645, 562648, 562649, 562652, 562653, 562654, 562655, 562656, 562657, 562658, 562659, 562665, 562666, 562667, 562668, 562670, 562673, 562674, 562675, 562676, 562677, 562679, 562680, 562681, 562682, 562683, 562684, 562687, 562688, 562689, 562690, 562692, 562693, 562694, 562695, 562697, 562699, 562702, 562703, 562704, 562706, 562707, 562708, 562

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States