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U.S. Department of Health and Human Services

Class 2 Device Recall IPC System

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 Class 2 Device Recall IPC Systemsee related information
Date Initiated by FirmDecember 15, 2021
Create DateApril 20, 2022
Recall Status1 Terminated 3 on June 09, 2023
Recall NumberZ-0961-2022
Recall Event ID 89847
510(K)NumberK081277 K081475 
Product Classification Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
ProductSoftware 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
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
Recalling Firm/
Manufacturer		 Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information ContactBrett Cromwell
904-296-9600
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 in Commerce1447 units
DistributionInternational distribution country of Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = ERL
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