FDAClass IIApril 27, 2022

Software 1898072 IPC upgrade v 2.7.3.0 recall: Software Issue

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)…

Why was Software 1898072 IPC upgrade v 2.7.3.0 recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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)…
Recalling firm
Medtronic Xomed, Inc.
Quantity
1447 units
Distribution
International distribution country of Japan.
Recall date
April 27, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls