FDAFDA · Alimentos y medicamentos·N.º oficial Z-0091-2026
Model Number L231, PROPONENT DR EL MRI Pacemaker
Publicado el 22 de octubre de 2025 · Inicio del retiro: 20 de agosto de 2025
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Boston Scientific Corporation
- Distribuidor
- Worldwide
- Lote
- GTIN 00802526559143, Serial Numbers: 756161, 799038, 841168. GTIN 00802526576423, Serial Numbers: 532638, 880141, 973836. GTIN 00802526578052, Serial Numbers: 594082, 727921, 812172, 832267, 899037, 944246, 978524. GTIN 00802526559143, Serial Numbers: 100008, 100026, 100030, 100038, 100045, 100046, 100052, 100053, 100059, 100061, 100066, 100077, 100078, 100079, 100081, 100083, 100087, 100088, 100099, 100104, 100105, 100108, 100114, 100126, 100130, 100134, 100136, 100142, 100148, 100151, 100153, 100154, 100156, 100161, 100162, 100163, 100164, 100165, 100168, 100172, 100175, 100178, 100180, 100181, 100187, 100188, 100190, 100191, 100193, 100196, 100199, 100201, 100203, 100205, 100206, 100207, 100208, 100210, 100212, 100213, 100216, 100218, 100220, 100235, 100236, 100243, 100244, 100245, 100246, 100247, 100251, 100252, 100253, 100254, 100256, 100261, 100265, 100275, 100279, 100280, 100282, 100283, 100288, 100289, 100292, 100293, 100294, 100296, 100299, 100300, 100302, 100305, 100306, 100307, 100308, 100309, 100310, 100314, 100316, 100317, 100318, 100322, 100326, 100327, 100328, 100329, 100333, 100335, 100339, 100340, 100341, 100342, 100345, 100348, 100350, 100352, 100358, 100361, 100364, 100365, 100366, 100367, 100368, 100370, 100371, 100372, 100373, 100375, 100376, 100377, 100379, 100381, 100389, 100395, 100409, 100411, 100412, 100414, 100415, 100416, 100417, 100418, 100438, 100439, 100441, 100442, 100443, 100444, 100445, 100447, 100448, 100449, 100450, 100451, 100452, 100454, 100455, 100456, 100458, 100459, 100460, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100468, 100469, 100471, 100472, 100473, 100474, 100475, 100476, 100477, 100479, 100480, 100481, 100482, 100483, 100484, 100488, 100491, 100494, 100497, 100507, 100516, 100517, 100518, 100519, 100523, 100529, 100531, 100532, 100541, 100543, 100554, 100555, 100558, 100560, 100566, 100586, 100588, 100589, 100595, 100596, 100598, 100609, 100610, 100613, 100614, 100623, 100624, 100625, 100627, 100628, 100629, 100631, 100633, 100634, 100637, 100638, 100640, 100641, 100647, 100648, 100649, 100650, 100651, 100652, 100654, 100656, 100659, 100662, 100665, 100666, 100667, 100668, 100673, 100674, 100675, 100676, 100677, 100678, 100679, 100680, 100681, 100682, 100683, 100684, 100688, 100691, 100693, 100695, 100698, 100699, 100700, 100703, 100708, 100709, 100710, 100713, 100718, 100720, 100722, 100723, 100725, 100726, 100727, 100728, 100729, 100730, 100731, 100732, 100733, 100734, 100735, 100736, 100738, 100746, 100750, 100755, 100756, 100758, 100759, 100764, 100767, 100768, 100769, 100775, 100780, 100781, 100782, 100784, 100800, 100801, 100802, 100804, 100809, 100816, 100831, 100841, 100885, 100889, 100892, 100899, 100902, 100904, 100910, 100912, 100919, 100927, 100933, 100953, 100972, 100991, 101003, 101012, 101028, 101030, 101289, 101327, 101341, 101356, 101357, 101366, 101383, 101389, 101391, 101394, 101407, 101412, 101417, 101419, 101433, 101439, 101441, 101445, 101449, 101451, 101452, 101455, 101461, 101463, 101473, 101475, 101477, 101480, 101490, 101495, 101498, 101500, 101505, 101511, 101514, 101516, 101524, 101525, 101532, 101539, 101552, 101554, 101558, 101559, 101562, 101563, 101574, 101576, 101577, 101580, 101587, 101589, 101595, 101599, 101604, 101606, 101609, 101610, 101611, 101613, 101618, 101626, 101629, 101631, 101641, 101680, 101682, 101685, 101687, 101688, 101690, 101713, 101720, 101728, 101736, 101739, 101750, 101753, 101755, 101760, 101764, 101765, 101768, 101769, 101773, 101774, 101776, 101782, 101787, 101788, 101794, 101795, 101796, 101808, 101811, 101813, 101815, 101822, 101823, 101825, 101829, 101832, 101834, 101835, 101836, 101841, 101843, 101852, 101857, 101858, 101859, 101864, 101868, 101869, 101871, 101873, 101880, 101882, 101884, 101886, 101888, 101890, 101891, 101892, 101893, 101896, 101899, 101900, 101901, 101908, 101911, 101918, 101922, 101923, 101924, 101928, 101932, 101933, 101934, 101935, 101936, 101937, 101938, 101940, 101941, 10
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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