Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 18980...
FDA Recall #Z-0961-2022 — Class II — December 15, 2021
Product Description
Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
Reason for Recall
As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.
Recalling Firm
Medtronic Xomed, Inc. — Jacksonville, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1447 units
Distribution
International distribution country of Japan.
Code Information
a) Product Number 1898001, GTIN 00613994752246, Lot Serial Numbers: 72158, 72162, 72167, 72178, 72176, 72205, 72206, 72208, 72234, 72323, 72315, 72326, 72339, 72340, 72342, 72372, 72404, 72419, 72422, 72471, 72509, 72492, 72788, 72818, 72819, 72815, 72816, 72838, 72843, 72639, 72607, 72630, 72632, 73117, 73114, 73115, 73122, 73204, 73206, 73218, 73554, 73354, 73355, 73358, 73359, 73351, 73384, 73408, 73410, 73416, 73420, 73421, 73427, 73431, 73432, 73433, 73430, 73434, 73508, 73510, 73507, 73509, 73539, 73540, 73560, 73561, 73604, 73830, 73844, 73847, 73848, 73851, 73852, 73853, 73855, 73846, 73859, 73856, 73863, 73864, 73874, 73875, 73877, 73878, 73879, 73992, 73993, 73994, 73995, 74014, 74017, 74016, 74036, 74033, 74046, 74047, 74048, 74050, 74055, 74057, 74061, 74062, 74227, 74229, 74231, 74232, 74310, 74313, 74314, 74315, 74317, 74353, 74354, 74386, 74385, 74394, 74434, 74436, 74512, 74577, 74571, 74587, 74590, 74592, 74594, 74595, 74596, 74646, 74647, 74644, 74674, 74763, 74766, 74770, 74769, 74773, 74854, 74880, 74881, 74899, 74900, 74978, 74979, 74980, 74982, 74988, 74989, 74991, 74992, 75008, 75144, 75166, 75206, 75226, 75272, 75313, 75315, 75317, 75422, 75423, 75424, 75426, 75428, 75430, 75456, 75459, 75460, 75462, 75492, 75493, 75495, 75494, 75526, 75529, 75543, 75708, 75709, 75710, 75711, 75712, 75713, 75714, 75725, 75726, 75727, 75769, 75848, 75849, 76056, 76090, 76129, 76127, 76145, 76169, 76171, 76334, 76335, 76360, 76363, 76365, 76362, 76413, 76414, 76476, 76492, 76537, 76589, 76592, 76667, 76668, 76669, 76742, 76744, 76745, 76746, 76747, 76748, 76749, 76797, 76801, 76810, 76811, ENTC77039, ENTC77041, ENTC77045, ENTC77047, ENTC77048, ENTC77122, ENTC77123, ENTC77138, ENTC77139, ENTC77141, ENTC77146, ENTC77180, ENTC77189, ENTC77194, ENTC77198, ENTC77199, ENTC77210, ENTC77496, ENTC77499, ENTC77500, ENTC77578, ENTC77584, ENTC77586, ENTC77587, ENTC77589, ENTC77591, ENTC77633, ENTC77697, ENTC77911, ENTC77912, ENTC77946, ENTC77949, ENTC77951, ENTC77993, ENTC77995, ENTC78052, ENTC78261, ENTC78262, ENTC78263, ENTC78264, ENTC78388, ENTC78390, ENTC78391, ENTC78393, ENTC78413, ENTC78453, ENTC78471, ENTC78472, ENTC78499, ENTC78577, ENTC78582, ENTC78596, ENTC78601, ENTC78659, ENTC78660, ENTC78683, ENTC78701, ENTC78704, ENTC78840, ENTC78842, ENTC78843, ENTC78983, ENTC78985, ENTC78986, ENTC78988, ENTC79028, ENTC79029, ENTC79030, ENTC78831, ENTC79060, ENTC79064, ENTC79088, ENTC79091, ENTC79092, ENTC79146, ENTC79147, ENTC79148, ENTC79149, ENTC79152, ENTC79154, ENTC79156, ENTC79157, ENTC79319, ENTC79361, ENTC79363, ENTC79364, ENTC79366, ENTC79367, ENTC79406, ENTC79409, ENTC79413, ENTC79417, ENTC79418, ENTC79419, ENTC79445, ENTC79449, ENTC79452, ENTC79467, ENTC79571, ENTC79598, ENTC79626, ENTC79627, ENTC79628, ENTC79629, ENTC79630, ENTC79633, ENTC79634, ENTC79637, ENTC79638, ENTC79656, ENTC79665, ENTC79666, ENTC79672, ENTC80074, ENTC80274, ENTC80276, ENTC80296, ENTC80480, ENTC80482, ENTC80483, ENTC80484, ENTC80506, ENTC80535, ENTC80551, ENTC80578, ENTC80582, ENTC80583, ENTC80625, ENTC80677, ENTC80678, ENTC80679, ENTC80680, ENTC80705, ENTC80707, ENTC80709, ENTC80710, ENTC80759, ENTC80816, ENTC80819, ENTC80837, ENTC80840, ENTC80873, ENTC80874, ENTC80875, ENTC80939, ENTC80941, ENTC80954, ENTC81013, ENTC81025, ENTC81031, ENTC81033, ENTC81035, ENTC81042, ENTC81044, ENTC81064, ENTC81070, ENTC81114, ENTC81116, ENTC81120, ENTC81121, ENTC81122, ENTC81123, ENTC81153, ENTC81262, ENTC81263, ENTC81458, ENTC81459, ENTC81496, ENTC81497, ENTC81499, ENTC81500, ENTC81505, ENTC81506, ENTC81507, ENTC81534, ENTC81535, ENTC81537, ENTC81615, ENTC81655, ENTC81657, ENTC81675, ENTC81690, ENTC81691, ENTC81692, ENTC81693, ENTC81694, ENTC81696, ENTC81697, ENTC81698, ENTC81782, ENTC81785, ENTC81786, ENTC81845, ENTC81846, ENTC81847, ENTC81849, ENTC81851, ENTC81852, ENTC82024, ENTC82027, ENTC82035, ENTC82036, ENTC82037, ENTC82083, ENTC82087, ENTC82090, ENTC82219, ENTC82223, ENTC82259, ENTC82263, ENTC82264, ENTC82275, ENTC82289, ENTC82290, ENTC82291, ENTC82294, ENTC82295, ENTC82302, ENTC82333, ENTC82664, ENTC82666, ENTC82687, ENTC82801, ENTC82806, ENTC82807, ENTC82809, ENTC82834, ENTC82835, ENTC82836, ENTC82856, ENTC82857, ENTC82862, ENTC82869, ENTC82873, ENTC82985, ENTC82987, ENTC82989, ENTC82992, ENTC82993, ENTC83174, ENTC83177, ENTC83181, ENTC83182, ENTC83185, ENTC83186, ENTC83187, ENTC83188, ENTC83190, ENTC83191, ENTC83208, ENTC83329, ENTC83333, ENTC83334, ENTC83370, ENTC83371, ENTC83372, ENTC83377, ENTC83378, ENTC83382, ENTC83384, ENTC83445, ENTC83446, ENTC83447, ENTC83715, ENTC83716, ENTC83722, ENTC83811, ENTC83814, ENTC83828, ENTC83829, ENTC83830, ENTC83831, ENTC83958, ENTC83964, ENTC83966, ENTC83969, ENTC83972, ENTC83973, ENTC84162, ENTC84173, ENTC84225, ENTC84271, ENTC84309, ENTC84314, ENTC84316, ENTC84320, ENTC84324, ENTC84406, ENTC84620, ENTC84623, ENTC84626 b) Product Number EC300RF, GTIN 00613994614629, Lot Serial Numbers: 51010, 51285, 51407, 51477, 51533, 51559, 51693, 51729, 52266, 52282, 52303, 52464, 52586, 53704, 53831, 54082, 54448, 54475, 54487, 54820, 55614, 57027 c) Product Number EC300, GTIN 00613994750167, Lot Serial Numbers: 52005, 52154, 52158, 52159, 52189, 52190, 52200, 52212, 52248, 52250, 52254, 52258, 52312, 52313, 52315, 52324, 52374, 52377, 52380, 52387, 52398, 52589, 52590, 52595, 52925, 53063, 53065, 53067, 53068, 53086, 53089, 53090, 53092, 53094, 53113, 53155, 53616, 53617, 53618, 53620, 53622, 53623, 53633, 53660, 53661, 53662, 53663, 53664, 53717, 53817, 53818, 53871, 53900, 53901, 53922, 53923, 53924, 53972, 53974, 53976, 53977, 53979, 53980, 53981, 53982, 53983, 53984, 53985, 53999, 54000, 54034, 54035, 54036, 54037, 54050, 54053, 54057, 54062, 54063, 54065, 54148, 54150, 54158, 54159, 54172, 54173, 54175, 54176, 54177, 54197, 54198, 54200, 54201, 54202, 54221, 54222, 54223, 54225, 54231, 54232, 54233, 54235, 54236, 54237, 54524, 54525, 54534, 54591, 54592, 54629, 54632, 54634, 54635, 54642, 54704, 54705, 54706, 54707, 54738, 54802, 54835, 54854, 54855, 54870, 54871, 54943, 54947, 54952, 54982, 54983, 55040, 55042, 55056, 55089, 55148, 55150, 55151, 55152, 55155, 55302, 55304, 55365, 55367, 55368, 55382, 55383, 55422, 55424, 55425, 55426, 55432, 55540, 55541, 55543, 55544, 55545, 55546, 55568, 55569, 55571, 55572, 55573, 55576, 55580, 55582, 55687, 55699, 55747, 55748, 55749, 55782, 55852, 55854, 55855, 56021, 56022, 56024, 56025, 56026, 56027, 56028, 56029, 56030, 56055, 56086, 56089, 56092, 56093, 56094, 56095, 56096, 56097, 56357, 56371, 56372, 56379, 56380, 56382, 56394, 56395, 56398, 56487, 56488, 56489, 56629, 56632, 56645, 56646, 56647, 56720, 56722, 56723, 56724, 56744, 56747, 56748, 56749, 56771, 56802, 56813, 56817, 56818, 56819, 56820, 56821, 56859, 56860, 56861, 56867, 56901, 56902, 56909, 56910, 56911, 56914, 56915, 57318, 57319, 57320, 57321, 57324, 57325, 57326, 57327, 57328, 57329, 57331, 57521, 57522, 57525, 57526, 57527, 57551, 57555, 57566, 57572, 57574, 57575, 57576, 57579, 57582, 57600, 57604, 57605, 57635, 57636, 57637, 57644, 57844, 57846, 57848, 57933, 57935, 57937, 57939, 57941, 57942, 57943, 58164, 58165, 58166, 58167, 58169, 58220, 58222, 58223, 58224, 58321, 58466, 58470, 58554, 58556, 58559, 58577, 58578, 58584, 58585, 58606, 58640, 58641, 58642, 58643, 58644, 58646, 58647, 58649, 58651, 58652, 58654, 58655, 58659, 58660, 58803, 58804, 58805, 58806, 58842, 58843, NTC59090, NTC59104, NTC59106, NTC59107, NTC59127, NTC59154, NTC59155, NTC59163, NTC59164, NTC59165, NTC59166, NTC59173, NTC59177, NTC59222, NTC59223, NTC59225, NTC59228, NTC59230, NTC59231, NTC59320, NTC59322, NTC59323, NTC59337, NTC59339, NTC59349, NTC59351, NTC59355, NTC59418, NTC59420, NTC59421, NTC59422, NTC59423, NTC59425, NTC59466, NTC59468, NTC59469, NTC59470, NTC59472, NTC59479, NTC59498, NTC59499, NTC59501, NTC59567, NTC59568, NTC59569, NTC59570, NTC59571, NTC59572, NTC59573, NTC59576, NTC59577, NTC59843, NTC59844, NTC59892, NTC59896, NTC59914, NTC59929, NTC59931, NTC59932, NTC59935, NTC59937, NTC59959, NTC59963, NTC59967, NTC59973, NTC59987, NTC59991, NTC59993, NTC60022, NTC60030, NTC60031, NTC60033, NTC60036, NTC60043, NTC60067, NTC60074, NTC60114, NTC60122, NTC60127, NTC60169, NTC60181, NTC60185, NTC60190, NTC60237, NTC60239, NTC60266, NTC60310, NTC60311, NTC60312, NTC60421, NTC60422, NTC60466, NTC60469, NTC60472, NTC60473, NTC60478, NTC60539, NTC60564, NTC60572, NTC60574, NTC60575, NTC60578, NTC60608, NTC60726, NTC60730, NTC60751, NTC60770, NTC60774, NTC60776, NTC60780, NTC60847, NTC60857, NTC60858, NTC60860, NTC60866, NTC60904, NTC60909, NTC60910, NTC60911, NTC60939, NTC60940, NTC60941, NTC60942, NTC60943, NTC61107, NTC61121, NTC61259, NTC61275, NTC61328, NTC61331, NTC61332, NTC61333, NTC61334, NTC61335, NTC61336, NTC61337, NTC61338, NTC61339, NTC61340, NTC61341, NTC61343, NTC61344, NTC61345, NTC61578, NTC61593, NTC61622, NTC61623, NTC61624, NTC61628, NTC61630, NTC61631, NTC61633, NTC61634, NTC61635, NTC61636, NTC61637, NTC61638, NTC61639, NTC61659, NTC61660, NTC61826, NTC61836, NTC61864, NTC61867, NTC61868, NTC61934, NTC61935, NTC61936, NTC61937, NTC61938, NTC61941, NTC61981, NTC62063, NTC62074, NTC62087, NTC62088, NTC62089, NTC62090, NTC62091, NTC62092, NTC62093, NTC62094, NTC62095, NTC62097, NTC62243, NTC62244, NTC62246, NTC62247, NTC62248, NTC62249, NTC62251, NTC62252, NTC62254, NTC62255, NTC62256, NTC62258, NTC62259, NTC62260, NTC62261, NTC62262, NTC62264, NTC62266, NTC62268, NTC62269, NTC62270, NTC62271, NTC62274, NTC62275, NTC62276, NTC62495, NTC62519, NTC62520, NTC62521, NTC62526, NTC62530, NTC62534, NTC62541, NTC62545, NTC62583, NTC62588, NTC62593, NTC62594, NTC62596, NTC62597, NTC62599, NTC62601, NTC62655, NTC62656, NTC62657, NTC62658, NTC62659, NTC62676, NTC62679, NTC62684, NTC62685, NTC62686, NTC62687, NTC62689, NTC62691, NTC63140, NTC63181, NTC63182, NTC63183, NTC63184, NTC63185, NTC63226, NTC63227, NTC63230, NTC63231, NTC63232, NTC63234, NTC63235, NTC63545, NTC63574, NTC63575, NTC63576, NTC63577, NTC63733, NTC63755, NTC63787, NTC63790, NTC63793, NTC63794, NTC63795, NTC63796, NTC64148, NTC64149, NTC64194, NTC64239, NTC64286, NTC64323, NTC64330, NTC64333, NTC64335, NTC64336, NTC64377, NTC64431, NTC64441, NTC64453, NTC64455, NTC64456, NTC64457, NTC64458, NTC64459, NTC64460, NTC64461, NTC64462, NTC64464, NTC64465, NTC64466, NTC64469, NTC64470, NTC64473, NTC64474, NTC64478, NTC64480, NTC64481, NTC64482, NTC64483, NTC64484, NTC64485, NTC64487, NTC64509, NTC64512, NTC64515, NTC64516, NTC64519, NTC64523, NTC64524, NTC64525, NTC64526, NTC64527, NTC64528, NTC64529, NTC64530, NTC64531, NTC64532, NTC64577, NTC64644, NTC64898, NTC64900, NTC64901, NTC64903, NTC64905, NTC65008, NTC65009, NTC65010, NTC65011, NTC65012, NTC65013, NTC65014, NTC65015, NTC65016, NTC65046, NTC65047, NTC65048, NTC65168, NTC65169, NTC65261, NTC65262, NTC65263, NTC65264, NTC65265, NTC65266, NTC65268, NTC65270, NTC65271, NTC65272, NTC65781, NTC65785, NTC65789, NTC65799, NTC65801, NTC65802, NTC65817, NTC65818, NTC65850, NTC65859, NTC65960, NTC65963, NTC65964, NTC65965, NTC65987, NTC65988, NTC65989, NTC65991, NTC65992, NTC65995, NTC66046, NTC66047, NTC66048, NTC66049, NTC66051, NTC66053, NTC66057, NTC66058, NTC66059, NTC66060, NTC66061, NTC66062, NTC66063, NTC66064, NTC66065, NTC66066, NTC66068, NTC66069, NTC66070, NTC66071, NTC66072, NTC66073, NTC66075, NTC66079, NTC66080, NTC66081, NTC66082, NTC66086, NTC66087, NTC66088, NTC66089, NTC66100, NTC66101, NTC66111, NTC66112, NTC66120, NTC66138, NTC66139, NTC66140, NTC66141, NTC66142, NTC66143, NTC66149, NTC66188, NTC66189, NTC66190, NTC66191, NTC66192, NTC66193, NTC66194, NTC66212, NTC66213, NTC66214, NTC66215, NTC66216, NTC66217, NTC66218, NTC66219, NTC66243, NTC66282, NTC66283, NTC66284, NTC66285, NTC66286, NTC66872, NTC66925, NTC66926, NTC66927, NTC66928, NTC66929, NTC66930, NTC66931, NTC66939, NTC66941, NTC66942, NTC66944, NTC66993, NTC66994, NTC66995, NTC66996, NTC66997, NTC66998, NTC66999, NTC67000, NTC67001, NTC67002, NTC67003, NTC67004, NTC67005, NTC67226, NTC67305, NTC67307, NTC67347, NTC67348, NTC67350, NTC67351, NTC67352, NTC67354, NTC67355, NTC67356, NTC67358, NTC67359, NTC67360, NTC67361, NTC67363, NTC67365, NTC67366, NTC67367, NTC67369, NTC67370, NTC67371, NTC67372, NTC67373, NTC67438, NTC67447, NTC67448, NTC67449, NTC67465, NTC67468, NTC67470, NTC67471, NTC67472, NTC67473, NTC67476, NTC67477, NTC67478, NTC67480, NTC67481, NTC67482, NTC67497, NTC67499, NTC67500, NTC67501, NTC67503, NTC67504, NTC67505, NTC67620, NTC67705, NTC67716, NTC67727, NTC67804, NTC67808, NTC68018, NTC68019, NTC68022, NTC68152, NTC68155, NTC68156, NTC68157, NTC68158, NTC68159, NTC68160, NTC68161, NTC68163, NTC68166, NTC68167, NTC68168, NTC68169, NTC68215, NTC68216, NTC68217, NTC68218, NTC68219, NTC68226, NTC68227, NTC68228, NTC68229, NTC68230, NTC68232, NTC68237, NTC68241, NTC68242, NTC68243, NTC68245, NTC68250, NTC68253, NTC68254, NTC68255, NTC68256, NTC68258, NTC68306, NTC68308, NTC68442, NTC68470, NTC68481, NTC68486, NTC68645, NTC68646, NTC68649, NTC68650, NTC68651, NTC68652, NTC68653, NTC68754, NTC68755, NTC68756, NTC68757, NTC69003, NTC69004, NTC69239, NTC69242, NTC69243, NTC69250, NTC69251, NTC69252, NTC69281, NTC69320, NTC69321, NTC69322, NTC69328, NTC69329, NTC69330, NTC69331, NTC69332, NTC69333, NTC69334, NTC69335, NTC69336, NTC69353, NTC69354, NTC69454, NTC69513, NTC69588, NTC69800, NTC71502
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.