🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 15, 2021 Medtronic Xomed Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Xomed, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0961-2022

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IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

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Due to out of the box wobble of the driver.

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NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164

Medtronic Xomed

Class I - Dangerous

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

Mar 10, 2025 Diagnostic Equipment Nationwide View Details →