Medtronic Xomed, Inc.: 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

Recall number

Z-0961-2022

Recalling firm

Medtronic Xomed, Inc.

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) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300

Status

Terminated

Initiated

2021-12-15

Posted

not on file

Terminated

2023-06-09

Reason

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.

Root cause

Under Investigation by firm

Action

The firm notified the Japanese consignees by letter on 12/12/2021. The letter stated the following: "In our company's records, the software version of your hospital's integrated power console (IPC) is not v2.7.3.0. However, we found that there were cases in other facilities that the software version was updated to v2.7.3.0 was not recorded in our company's records even though the software version was updated to v2.7.3.0.. Therefore, we proceed the following measures. Thank you for your understanding and cooperation. Content l If it has been confirmed that the software used in your hospital is v2.7.3.0, please contact your Medtronic representative or distributor representative and suspend to use with the M5 handpiece (the method of checking the software version is described in the separate sheet). l Medtronic representative or distributor representative contact and visit to check the software version of your hospital's IPC."

Quantity

1447 units

Distribution

International distribution country of Japan.

Lot, serial or model codes

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

510(k) numbers

["K081277","K081475"]

PMA numbers

not on file

Product code

ERL

Firm FEI

1045254

Firm city

Jacksonville

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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