Z-1104-2022 Class II Ongoing

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420

Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.

GTIN 00888707000420, Serial Numbers: CON301559, CON301671, CON301680, CON301691, CON301692, CON301699, CON301714, CON301828, CON302225, CON302283, CON302286, CON302325, CON303175, CON303662, CON303733, CON303773, CON304089, CON304110, CON304225, CON304349, CON300543, CON300552, CON300553, CON300556, CON300619, CON300621, CON300623, CON300628, CON300638, CON300902, CON301367, CON301375, CON301485, CON301625, CON301674, CON301708, CON301870, CON301935, CON301943, CON301978, CON301996, CON302001, CON302013, CON302049, CON302113, CON302127, CON302138, CON302142, CON302143, CON302162, CON302165, CON302169, CON302172, CON302177, CON302180, CON302182, CON302183, CON302199, CON302227, CON302250, CON302262, CON302268, CON302281, CON302285, CON302299, CON302322, CON302327, CON302331, CON302336, CON302349, CON302366, CON302369, CON302371, CON302373, CON302374, CON302375, CON302387, CON302391, CON302394, CON302397, CON302399, CON302408, CON302412, CON302415, CON302420, CON302423, CON302436, CON302441, CON302443, CON302445, CON302446, CON302450, CON302451, CON302456, CON302458, CON302460, CON302465, CON302470, CON302471, CON302472, CON302474, CON302491, CON302496, CON302505, CON302508, CON302510, CON302511, CON302515, CON302522, CON302525, CON302535, CON302538, CON302539, CON302540, CON302543, CON302544, CON302546, CON302555, CON302556, CON302557, CON302560, CON302561, CON302562, CON302566, CON302567, CON302577, CON302581, CON302584, CON302595, CON302601, CON302613, CON302614, CON302619, CON302621, CON302623, CON302629, CON302664, CON302666, CON302667, CON302671, CON302673, CON302679, CON302698, CON302699, CON302706, CON302709, CON302710, CON302712, CON302716, CON302721, CON302722, CON302723, CON302724, CON302725, CON302727, CON302730, CON302745, CON302751, CON302752, CON302753, CON302759, CON302765, CON302770, CON302775, CON302776, CON302783, CON302785, CON302787, CON302801, CON302809, CON302815, CON302817, CON302822, CON302827, CON302834, CON302838, CON302840, CON302846, CON302847, CON302850, CON302852, CON302856, CON302858, CON302861, CON302864, CON302865, CON302866, CON302875, CON302876, CON302877, CON302884, CON302885, CON302887, CON302897, CON302898, CON302899, CON302906, CON302908, CON302911, CON302912, CON302921, CON302925, CON302929, CON302930, CON302932, CON302939, CON302942, CON302945, CON302949, CON302950, CON302958, CON302959, CON302961, CON302963, CON302964, CON302967, CON302971, CON302981, CON303001, CON303038, CON303039, CON303040, CON303041, CON303049, CON303051, CON303055, CON303063, CON303080, CON303088, CON303098, CON303100, CON303113, CON303119, CON303134, CON303142, CON303143, CON303148, CON303150, CON303152, CON303153, CON303154, CON303183, CON303213, CON303242, CON303259, CON303266, CON303280, CON303288, CON303328, CON303332, CON303339, CON303373, CON303382, CON303389, CON303397, CON303410, CON303456, CON303468, CON303551, CON303552, CON303565, CON303577, CON303593, CON303600, CON303601, CON303604, CON303606, CON303610, CON303614, CON303619, CON303623, CON303626, CON303635, CON303673, CON303716, CON303727, CON303729, CON303732, CON303738, CON303746, CON303778, CON303780, CON303822, CON303831, CON303833, CON303907, CON303913, CON303914, CON303916, CON303953, CON303959, CON303965, CON303983, CON303988, CON303989, CON304085, CON304093, CON304098, CON304107, CON304116, CON304117, CON304124, CON304132, CON304133, CON304134, CON304138, CON304164, CON304170, CON304186, CON304190, CON304191, CON304194, CON304204, CON304206, CON304207, CON304208, CON304209, CON304210, CON304212, CON304213, CON304214, CON304215, CON304217, CON304218, CON304222, CON304228, CON304229, CON304255, CON304259, CON304272, CON304274, CON304275, CON304281, CON304284, CON304287, CON304294, CON304296, CON304298, CON304321, CON304326, CON304330, CON304335, CON304388, CON304408, CON304411, CON304417, CON304419, CON304427, CON304440, CON304515, CON304531, CON304540, CON304542, CON304544, CON304545, CON304546, CON304547, CON304552, CON304573, CON304595, CON304603, CON304607, CON304612, CON304616, CON304617, CON304629, CON304633, CON304644, CON304648, CON304650, CON304667, CON304668, CON304673, CON304680, CON304685, CON304695, CON304697, CON304699, CON304708, CON304713, CON304723, CON304730, CON304741, CON304742, CON304743, CON304746, CON304747, CON304748, CON304749, CON304751, CON304752, CON304760, CON304775, CON304786, CON304787, CON304805, CON304810, CON304821, CON304822, CON304826, CON304829, CON304832, CON304835, CON304839, CON304840, CON304849, CON304852, CON304856, CON304857, CON304863, CON304870, CON304883, CON304884, CON304888, CON304892, CON304893, CON304894, CON304895, CON304898, CON304900, CON304903, CON304922, CON304930, CON304931, CON304932, CON304963, CON304964, CON304966, CON304970, CON304971, CON304973, CON304975, CON304976, CON304977, CON304979, CON304980, CON304982, CON304984, CON304985, CON304990, CON304992, CON305001, CON305003, CON305004, CON305010, CON305014, CON305015, CON305016, CON305018, CON305021, CON305025, CON305026, CON305028, CON305030, CON305031, CON305033, CON305034, CON305035, CON305036, CON305038, CON305039, CON305042, CON305043, CON305044, CON305045, CON305047, CON305049, CON305050, CON305055, CON305057, CON305059, CON305063, CON305070, CON305072, CON305075, CON305078, CON305080, CON305085, CON305091, CON305093, CON305094, CON305096, CON305102, CON305122, CON305125, CON305126, CON305127, CON305133, CON305134, CON305135, CON305137, CON305138, CON305140, CON305149, CON305179, CON305190, CON305211, CON305226, CON305232, CON305233, CON305234, CON305238, CON305239, CON305241, CON305243, CON305244, CON305248, CON305250, CON305367, CON305400