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Crédits
Manufacturers
Mini-Mitter Company, Inc.
Adresse du fabricant
Mini-Mitter Company, Inc., 20300 Empire Ave Ste B3, Bend OR 97701
Société-mère du fabricant (2017)
Mini Mitter Co Inc
Source
USFDA
4 Events
Rappel de Device Recall Actiwatch 16
Rappel de Device Recall Actiwatch 64 AM,
Rappel de Device Recall Actical
Rappel de Device Recall Actiwatch
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4 dispositifs dans la base de données
Device Recall Actiwatch 16
Modèle / numéro de série
Serial Numbers: V960700, V960703, V960735, V960739, V960740, V960864, V960865, V960866, V960868, V960869, V960870, V961013, V961014, V961015, and V960659.
Classification du dispositif
Neurological Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide
Description du dispositif
Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup pkg Part Number 198-1000-00.
Device Recall Actiwatch 64 AM,
Modèle / numéro de série
Serial Numbers: V960132, V960133, V960135, V960191, V960253, V960254, V960255, V960256, V960257, V960314, V960460, V960461, V960469, V960481, V960483, V960487, V960488, V960504, V960505, and V960550
Classification du dispositif
Neurological Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide
Description du dispositif
Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company, Bend, Oregon
Device Recall Actical
Modèle / numéro de série
Serial Numbers: B100001, B100002, B100003, B100005, B100006, B100007, B100008, B100009, B100023, B100024, B100025, B100026, B100027, B100028, B100029, B100030, B100031, B100032, B100033, B100034, B100035, B100036, B100037, B100038, B100039, B100041, B100042, B100043, B100044, B100045, B100046, B100047, B100048, B100049, B100050, B100051, B100052, B100053, B100054, B100055, B100056, B100057, B100058, B100059, B100060, B100061, B100062, B100063, B100064, B100065, B100066, B100067, B100068, B100069, B100070, B100071, B100072, B100073, B100074, B100075, B100076, B100077, B100078, B100079, B100080, B100081, B100082, B100083, B100084, B100085, B100086, B100087, B100088, B100089, B100090, B100091, B100092, B100093, B100094, B100095, B100096, B100097, B100098, B100099, B100100, B100101, B100102, B100103, B100104, B100105, B100106, B100107, B100108, B100109, B100110, B100111, B100112, B100113, B100114, B100115, B100116, B100117, B100118, B100119, B100120, B100121, B100122, B100123, B100124, B100125, B100126, B100127, B100128, B100129, B100130, B100131, B100132, B100133, B100134, B100135, B100136, B100137, B100138, B100139, B100140, B100141, B100142, B100143, B100144, B100145, B100146, B100147, B100148, B100149, B100150, B100151, B100152, B100153, B100154, B100155, B100156, B100157, B100158, B100159, B100160, B100161, B100162, B100163, B100164, B100165, B100166, B100167, B100168, B100169, B100170, B100171, B100172, B100173, B100174, B100175, B100176, B100177, B100178, B100179, B100180, B100181, B100182, B100183, B100184, B100185, B100186, B100187, B100188, B100189, B100190, B100191, B100192, B100193, B100194, B100195, B100196, B100197, B100198, B100199, B100200, B100201, B100202, B100203, B100204, B100205, B100206, B100207, B100208, B100209, B100210, B100211, B100212, B100213, B100214, B100215, B100216, B100217, B100218, B100219, B100220, B100221, B100222, B100223, B100224, B100225, B100226, B100227, B100228, B100229, B100230, B100231, B100232, B100233, B100234, B100235, B100236, B100237, B100238, B100239, B100240, B100241, B100242, B100243, B100244, B100245, B100246, B100247, B100248, B100249, B100250, B100251, B100252, B100253, B100254, B100255, B100256, B100257, B100258, B100259, B100260, B100261, B100262, B100263, B100264, B100265, B100266, B100267, B100268, B100269, B100270, B100271, B100272, B100273, B100274, B100275, B100276, B100277, B100278, B100279, B100280, B100281, B100282, B100283, B100284, B100285, B100286, B100287, B100288, B100289, B100290, B100291, B100292, B100293, B100294, B100295, B100296, B100297, B100298, B100299, B100300, B100301, B100302, B100303, B100304, B100305, B100306, B100307, B100308, B100309, B100310, B100311, B100312, B100313, B100314, B100315, B100316, B100317, B100318, B100319, B100320, B100321, B100322, B100323, B100324, B100325, B100326, B100327, B100328, B100329, B100330, B100331, B100332, B100333, B100334, B100335, B100336, B100337, B100338, B100339, B100340, B100341, B100342, B100343, B100344, B100345, B100346, B100347, B100348, B100349, B100350, B100351, B100352, B100353, B100354, B100355, B100356, B100357, B100358, B100359, B100360, B100361, B100362, B100363, B100364, B100365, B100366, B100367, B100368, B100369, B100370, B100371, B100372, B100373, B100374, B100375, B100376, B100377, B100378, B100379, B100380, B100381, B100382, B100383, B100384, B100385, B100386, B100387, B100388, B100389, B100390, B100391, B100392, B100393, B100394, B100395, B100396, B100397, B100398, B100399, B100400, B100401, B100402, B100403, B100406, B100407, B100408, B100409, B100410, B100411, B100412, B100413, B100414, B100415, B100416, B100417, B100418, B100419, and B100420
Classification du dispositif
Neurological Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide
Description du dispositif
Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend, Oregon
Device Recall Actiwatch
Modèle / numéro de série
Serial Numbers: V960641, V960642, V960655, V960656, V960657, V960658, V960660, V960661, V960986, V961113, V961114, V961115, V961116, V961117, V961118, V961119, V961120, V961177, V961178, V961179, V961180, V961181, V961182, V961183, V961184, V961185, V961186, V961187, V961188, V961189, V961191, V961192, V961193, V961194, V961195, V961196, V961197, V961198, V961199, V961200, V961513, V961514, V961515, V961516, V961517, V961518, V961519, V961520, V961593, V961594, V961595, V961596, V961597, V961598, V961599, V961600, V961601, V961602, V961603, V961604, V961605, V961606, V961607, V961608, V961609, V961610, V961611, V961612, V961613, V961614, V961615, V961616, V961617, V961121, V961122, V961123, V961124, V961125, V961126, V961127, V961128, V961321, V961322, V961323, V961324, V961325, V961326, V961327, V961328, V961329, V961330, V961331, V961332, V961333, V961334, V961335, V961336, V961337, V961338, V961339, V961340,V960611, V960617, V960618, V960619, V960620, V960621, V960622, V960629, V960630, V960631, V960632, V960635, V960638, V960639, V960640, V960643, V960644, V960645, V960663, V960669, V960671, V960673, V960678, V960681, V960682, V960684, V960685, V960686, V960689, V960690, V960692, V960693, V960694, V960695, V960696, V960697, V960698, V960701, V960702, V960709, V960710, V960720, V960721, V960722, V960723, V960724, V960725, V960726, V960728, V960729, V960730, V960731, V960732, V960736, V960737, V960742, V960743, V960744, V960745, V960746, V960747, V960748, V960749, V960751, V960752, V960753, V960754, V960755, V960757, V960758, V960760, V960761, V960834, V960835, V960836, V960837, V960838, V960839, V960840, V960841, V960842, V960843, V960844, V960845, V960846, V960847, V960848, V960849, V960850, V960851, V960854, V960855, V960856, V960857, V960858, V960859, V960860, V960861, V960862, V960863, V960871, V960872, V960875, V960876, V960877, V960878, V960879, V960882, V960889, V960891, V960892, V960893, V960894, V960895, V960896, V960897, V960898, V960900, V960902, V960903, V960904, V960913, V960914, V960915, V960916, V960917, V960918, V960919, V960920, V960921, V960922, V960923, V960924, V960925, V960928, V960929, V960930, V960931, V960932, V960933, V960934, V960935, V960936, V960937, V960938, V960939, V960940, V960941, V960942, V960943, V960944, V960945, V960946, V960947, V960948, V960949, V960950, V960951, V960952, V960953, V960954, V960955, V960956, V960957, V960958, V960959, V960960, V960961, V960962, V960963, V960964, V960965, V960966, V960967, V960968, V960969, V960970, V960971, V960972, V960973, V960974, V960975, V960976, V960977, V960978, V960979, V960980, V960981, V960982, V960983, V960984, V960993, V961009, V961016, V961017, V961018, V961021, V961023, V961024, V961025, V961026, V961027, V961028, V961029, V961030, V961032, V961034, V961035, V961036, V961038, V961039, V961040, V961042, V961043, V961044, V961045, V961047, V961048, V961049, V961050, V961051, V961052, V961053, V961054, V961056, V961057, V961058, V961059, V961060, V961064, V961066, V961067, V961068, V961130, V961134, V961144, V961145, V961146, V961147, V961148, V961149, V961150, V961151, V961152, V961201, V961202, V961203, V961204, V961205, V961206, V961207, V961208, V961209, V961210, V961211, V961212, V961213, V961214, V961215, V961216, V961260, V961278, V961283, V961320, V961348, V961351, V961352, V961353, V961354, V961355, V961356, V961357, V961358, V961360, V961367, V961368, V961369, V961370, V961371, V961372, V961373, V961374, V961375, V961376, V961377, V961378, V961379, V961381, V961382, V961383, V961388, V961389, V961390, V961391, V961392, V961393, V961394, V961396, V961397, V961398, V961399, V961400, V961401, V961402, V961403, V961404, V961405, V961406, V961407, V961408, V961409, V961410, V961411, V961412, V961413, V961414, V961415, V961416, V961417, V961418, V961419, V961420, V961421, V961422, V961423, V961424, V961425, V961426, V961427, V961428, V961429, V961430, V961431, V961432, V961433, V961434, V961435, V961436, V961437, V961438, V961439, V961440, V961442, V961444, V961445, V961446, V961447, V961448, V961449, V961450, V961451, V961452, V961453, V961454, V961455, V961456, V961457, V961458, V961459, V961460, V961461, V961462, V961463, V961464, V961465, V961466, V961467, V961468, V961469, V961470, V961471, V961472, V961473, V961474, V961475, V961476, V961477, V961478, V961479, V961480, V961481, V961485, V961486, V961487, V961488, V961510, V961511, V961512, V961521, V961522, V961523, V961524, V961525, V961526, V961529, V961530, V961531, V961532, V961534, V961535, V961536, V961538, V961539, V961540, V961542, V961543, V961544, V961545, V961546, V961547, V961548, V961549, V961550, V961551, V961552, V961553, V961554, V961555, V961556, V961561, V961591, V961592, V961625, V961626, V961627, V961628, V961629, V961630, V961631, V961632, V961633, V961634, V961635, V961636, V961637, V961638, V961639, V961640, V961641, V961642, V961643, V961644, V961645, V961647, V961648, V961649, V961650, V961652, V961653, V961654, V961655, V961656, V961689, V961690, V961691, V961692, V961693, V961694, V961695, V961696, V961697, V961698, V961699, V961700, V961701, V961702, V961703, V961704, V961705, V961706, V961707, V961708, V961713, V961714, V961715, V961716, V961717, V961718, V961727, V961728, V961729, V961730, V961731, V961732, V961733, V961735, V961736, V961737, V961738, V961739, V961740, V961741, V961742, V961896, V961897, V961900, V961901, V961902, V961903, V961904, V961905, V961906, V961907, V961908, V961909, V961910, V961569, V961570, V961571, V961572, V961573, V961574, V961575, V961576, V961752, V961753, V961754, V961755, V961756, V961757, V961758, V961759, V961760, V961761, V961762, V961763, V961764, V961765, V961766, V961768, V961769, V961770, V961771, and V961772.
Classification du dispositif
Neurological Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide
Description du dispositif
Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM; Actiwatch 64 Part Number 198-0301-00; Actiwatch 64 AM Part Number 198-0301-AM, Mini Mitter, a Respironics Company, Bend, Oregon
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