Invivo Corporation: Medical Device Recall in 2020 - (Recall #: Z-0126-2021)

MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

Class III

The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.

Models: dS Knee Sch 3.0T, dS Knee Sch 1.5T, dS HiRes Hand/Wrist 16ch 1.5T, dS HiRes Hand/Wrist, dS Shoulder 16ch 3, dS Shoulder 16ch 1.5T, dS Shoulder Sch 1.ST,dS Shoulder Sch 3.0T. Part Numbers: 4522-150-40202, 4522-150-40362, 4535-300-54581, 4535-300-71071, 4535-300-71271, 4535-300-71281, 535-302-77861, 4535-302-77871, 4535-302-77891, 4535-302-94611, 4535-302-94612, 4535-302-94613, 4535-302-94621, 4535-302-94623, 4535-303-59931, 4535-303-59951, 4535-303-59953, 4535-303-59971, 4535-303-59973, 4535-303-60031, 4535-303-60033, 4535-303-60051, 4535-303-60053, 4535-303-60071, 4535-303-60073, 4535-303-60751, 4535-303-60771, 4598-000-97974, 4598-000-97984, 4598-000-97994, 4598-012-90041, 4598-012-90042, 4598-012-90051, 598-012-90061, 4598-012-95531, 4598-013-12411, 4598-014-99951, 4598-014-99971, 4598-014-99991, 4598-015-00031, 4598-015-00051, 4598-015-00071, 9896-030-13432, 9896-030-13972, 9896-030-24282, 9896-030-24402, 4598-012-91131, 4598-012-95481, 9896-032-00441, 9896-032-00442, 9896-032-00443, 9896-032-00451, 9896-032-00453, 9896-032-08011, 9896-032-08021, 9896-032-08031, 9896-032-08051, 9896-032-08061, 9896-032-08071, 9896-032-15621, 9896-032-15671, 9896-032-15681, 9896-032-15682, 9896-032-15691, 9896-032-15692, 9896-032-15731, 9896-032-15741, 9896-032-15751, 4598-012-90062, 4598-012-90091, 4598-012-90101, 4598-012-90102, 4598-012-90121, 4598-012-90122, 4598-012-90261, 4598-012-90601, 4598-012-90631, 4598-012-90831, 4598-012-90891, 4598-012-90892, 9896-032-15821, 9896-032-15822, 9896-032-16021, 9896-032-16031, 9896-032-16032, 9896-032-16041, 9896-032-16042, 9896-032-16091, 9896-032-16161, 9896-032-16301, 9896-032-16321. Serial Numbers: 5250, 5468, 50474, 5275, 5280, 5244, 5282, 5497,5253, 5503,5255, 50512, 5516, 5518, 5256, 50510, 5509, 5278, 5508, 50525, 5361, 5532, 50545, 50543, 5272, 2020, 5530, 50549, 5311, 2019, 5309, 50555, 50552, 5786, 5438, 5322, 50589, 5591, 5447, 5587, 5327, 50599, 5597, 50591, 5598, 5341, 5809, 5413, 5463, 50612, 5629, 5340, 5416, 5616, 50626, 5345, 5348, 5648, 5471, 5360, 5484, 5816, 5429, 5798, 5497, 5426, 5675, 5367, 50671, 5640, 5352, 50658, 5693, 5481, 5828, 5446, 5641, 5350, 50667, 5682, 5643, 50655, 50650, 5686, 5380, 5639, 50653, 50694, 5719, 5477, 50761, 5751, 5497, 50721, 5499, 5757, 5755, 50772, 5509, 50750, 5772, 5511, 5574, 5370, 50797, 17888, 5839, 5503, 5589, 5746, 50787, 50785, 17898, 5502, 5579, 5877, 5876, 5786, 5702, 5469, 50821, 5781, 5523, 5813, 5897, 50846, 17943, 5873, 5558, 5818, 17958, 5502, 50873, 17969, 50864, 17952, 50868, 17956, 5536, 5490, 18011, 5896, 5850, 5904, 5849, 5616, 5899, 5621, 5884, 5857, 5615, 5891, 5833, 5614, 5887, 5599, 5585, 5943, 5891, 17983, 5578, 5902, 5875, 5638, 18034, 50956, 5924, 5878, 5632, 50986, 18081, 5540, 50959, 18095, 50962, 5651, 5911, 5956, 5554, 5555, 5556, 18010, 18057, 50980, 1, 14, 10, 10, 5933, 5903, 5648, 5547, 50967, 5568, 18046, 18061, 50997, 17989, 51024, 5563, 5567, 5561, 18072, 19, 13, 14, 18071, 51022, 18068, 51009, 5566, 51030, 5675, 5565, 18160, 51047, 5596, 18096, 51002, 51004, 18138, 18105, 5601, 51006, 18161, 18168, 5629, 18106, 5632, 18112, 5628, 5572, 18080, 11, 11, 9, 9, 5593, 18131, 51059, 51057, 5591, 5715, 16, 23, 5953, 5709, 13, 16, 51067, 23, 18024, 12, 5594, 51063, 51051, 51073, 6, 27, 15, 51071, 51072, 5983, 21, 17, 31, 51060, 18, 33, 29, 6, 36, 5936, 5705, 10, 25, 19, 50, 37, 61, 76, 75, 76, 74, 5590, 18151, 106, 96, 101, 58, 88, 53, 96, 90, 95, 50, 64, 115, 108, 65, 61, 52, 63, 32, 15, 38, 46, 95, 61, 111, 28, 68, 57, 105, 130, 133, 17, 157, 24, 38, 75, 143, 166, 67, 66, 79, 194, 139, 93, 167, 47, 71, 66, 153, 163, 46, 45, 39, 154, 43, 129, 199, 79, 173, 70, 5585, 97, 105, 72, 12, 198, 183, 174, 236, 77, 56, 73, 67, 166, 52, 26, 80, 159, 11, 220, 242, 230, 78, 119, 238, 264, 12, 184, 195, 230, 13, 15, 203, 234, 194, 89, 54, 75, 56, 185, 100, 18, 210, 180, 84, 206, 204, 210, 99, 244, 35, 164, 232, 228, 201, 60, 224, 248, 22, 41, 79, 124, 291, 299, 246, 257, 236, 111, 54, 19, 334, 193, 52, 309, 363, 194, 42, 98, 255, 247, 270, 118, 28, 252, 322, 198, 17, 231, 273, 267, 7, 237, 271, 266, 120, 117, 258, 318, 109, 91, 305, 343, 151, 55, 90, 89, 48, 92, 304, 345, 73, 302, 342, 115, 52, 286, 42, 10, 200, 199, 262, 14, 203, 263, 264, 162, 390, 225, 1024, 58, 398, 1017, 220, 134, 328, 29, 225, 332, 85, 145, 423, 56, 97, 371, 1004, 1001, 18, 264, 66, 306, 73, 96, 148, 353, 426, 98, 144, 58, 415, 109, 400, 335, 337, 172, 231, 168, 112, 176, 18176, 18164, 18183, 219, 341, 341, 437, 138, 136, 173, 337, 169, 444, 441, 222, 55, 170, 137, 1021, 192, 153, 483, 252, 494, 475, 196, 136, 507, 189, 84, 73, 135, 496, 188, 4, 54, 187, 71, 1084, 505, 258, 1119, 76, 70, 81, 38, 159, 190, 63, 24, 379, 1085, 1097, 1081, 37, 103, 388, 88, 45, 23, 158, 203, 357, 104, 1005, 152, 34, 90, 127, 352, 533, 1148, 1053, 217, 397, 46, 1002, 126, 29, 1056, 1167, 1177, 564, 100, 432, 1164, 1160, 1072, 1178, 1153, 1231, 229, 624, 470, 401, 306, 308, 387, 520, 520, 521, 432, 411, 544, 89, 419, 322, 236, 341, 5029, 50015, 538, 5021, 50024, 5005, 5046, 5024, 5028, 5013, 5026, 5054, 5028, 5036, 5038, 5063, 5043, 5046, 5049, 5053, 5042, 50054, 5094, 5065, 345, 5082, 50098, 50061, 5047, 5062, 408, 5114, 5073, 5026, 5071, 5079, 5054, 5099, 50077, 5088, 5048, 5087, 5087, 50160, 5156, 50138, 5073, 5091, 5078, 5161, 50166, 5084, 5100, 5135, 5134, 50141, 5135, 50137, 5090, 5105, 716, 5091, 5169, 5166, 748, 50181, 5131, 5245, 50249, 5111, 5103, 5161, 5123, 5160, 5240, 50218, 5269, 5259, 50262, 5180, 50265, 5320, 5159, 5215, 5199, 50273, 5374, 5167, 50271, 5385, 5159, 50363, 5392, 5168, 5391, 50389, 5188, 5283, 5198, 5295, 5268, 5218, 5407, 50405, 5186, 5301, 5298, 5222, 5302, 5308, 50435, 5454, 5260, 5449, 50444, 1056, 1200, 226, 1043, 1191, 587, 1048, 1170, 641, 1061, 1203, 224, 645, 1066, 1221, 230, 648, 60, 1049, 1227, 596, 244, 81, 588, 1232, 228, 301672111, 11, 165, 102, 1090, 6, 176, 83, 99, 1088, 431, 600, 8, 153, 105, 1086, 84, 428, 665, 1176, 1062, 283, 675, 79, 1174, 1060, 231, 637, 33, 115, 165, 301672120, 1305, 701, 56, 430, 111, 208, 1120, 163, 301672119, 1301, 719, 1051, 51, 109, 221, 57, 110, 227, 1123, 219, 656, 1302, 301672145, 1037, 1192, 713, 310, 74, 215, 1313, 717, 116, 76, 1207, 1165, 179, 52, 1107, 229, 1010, 290, 1283, 735, 1156, 1239, 234, 124, 76, 1034, 1278, 247, 777, 1013, 1345, 722, 266, 262, 1114, 74, 1226, 236, 301672139, 1365, 756, 71, 1182, 704, 267, 301672157, 664, 301672134, 381, 265, 1391, 361, 273, 751, 7007007014, 1199, 750, 301672174, 86, 156, 844, 7007007013, 7007007038, 1213, 364, 279, 850, 7007007015, 127, 112, 20, 103, 1113, 234, 97, 1121, 1191, 230, 4500833643, 102, 7, 1105, 836451, 469, 852, 301672129, 7007007020, 876, 301672127, 760, 303, 7007007052, 301672125, 775, 330, 7007007009, 7007007011, 886, 7007007048, 7007007006, 890, 7007007044, 1020, 322, 908, 7007007092, 301672124, 843, 7007007100, 1363, 7007007019, 885, 301672130, 839, 7007007105, 67, 1329, 321, 848, 340, 905, 7007007065, 7007007034, 41, 9009009018, 8008008069, 301672131, 894, 7007007069, 318, 264, 301672115, 7007007094, 396, 944, 320, 322, 323, 140, 306, 305, 949, 7007007039, 7007007181, 284, 7007007098, 1014, 7007007064, 40, 45, 36, 836453, 8008008040, 275, 30, 836479, 8008008099, 68, 5092, 5100, 5102, 5273, 5277, 5287, 5122, 5172, 5130, 5151, 5133, 5134, 5205, 5141, 5144, 5178, 5376, 5240, 5241, 5201, 5, 14, 10, 5434, 5435, 5433, 5233, 11, 14, 9, 5271, 44, 44, 45, 43, 42, 5295, 5261, 122, 107, 53, 111, 153, 157, 126, 125, 250, 5494, 77, 13, 73, 126, 42, 131, 44, 79, 135, 81, 153, 87, 89, 87, 1071, 184, 112, 115, 271, 5028, 36595, 5056, 5089, 5147, 5087, 5088, 743, 154, 1109, 926, 1174, 180, 270, 1050, 1053, 1048, 1069, 106, 8008008119, 7007007076, 7007007077, 7007007084, 5087, 20, 5229, 36592, 35360, 56, 25497, 5257, 5106, 19, 54, 5111, 5270, 5141, 5117, 5289, 5164, 5292, 5126, 122, 5092, 5303, 5038, 5009, 101, 5041, 5115, 5131, 5133, 5019, 5073, 5158, 5137, 5136, 5023, 5194, 5020, 5130, 5112, 5161, 5198, 5293, 5142, 5324, 5011, 5145, 5329, 5002, 5138, 5148, 34528, 5164, 5146, 5215, 5154, 5066, 5030, 5221, 5347, 5159, 36606, 5367, 5174, 5030, 5124, 29, 5174, 5019, 30174, 5127, 36599, 5208, 5113, 36609, 106, 36611, 5391, 5104, 5215, 169, 5213, 5137, 5140, 5185, 5088, 174, 5351, 5099, 5006, 35315, 29003, 35379, 5256, 5400, 5245, 5190, 130, 5247, 5178, 5188, 5191, 5150, 5117, 5187, 5226, 5099, 22198, 41, 5069, 5039, 5069, 5067, 6018, 5192, 5200, 5200, 31819, 5208, 5252, 5205, 5209, 5315, 5366, 5069, 5206, 5012, 5257, 5212, 176, 6044, 5401, 5213, 5419, 35367, 34543, 36784, 5098, 6033, 36785, 34540, 35365, 5171, 2080, 5256, 5266, 35338, 5267, 6067, 5437, 5330, 5221, 6092, 5035, 34525, 5105, 5225, 5237, 5449, 36613, 5045, 156, 5036, 86, 5355, 5288, 60, 41, 29886, 5243, 5213, 36593, 5047, 5244, 155, 5250, 5204, 5292, 5153, 5246, 5276, 5055, 5257, 5357, 5050, 5182, 5215, 5086, 5169, 36791, 5293, 5160, 5470, 5468, 5249, 5240, 53, 5227, 5252, 5251, 36794, 5235, 5250, 97, 36550, 56, 36603, 5299, 5305, 63, 93, 5261, 5278, 5258, 19, 5320, 5308, 11, 35329, 5032, 5498, 5312, 5497, 5496, 5315, 5500, 89, 130, 5318, 2, 6, 4, 2, 5031, 17, 9, 8, 4, 18, 22, 9, 11, 23, 9, 14, 17, 24, 29, 27, 18, 52, 39, 47, 5540, 36615, 23294, 1151, 58, 59, 5059, 9, 1240, 5558, 5259, 5530, 5346, 18, 5343, 5351, 5251, 36519, 13, 84, 82, 75, 83, 202, 76, 80, 74, 5545, 1361, 5569, 81, 90, 170, 173, 172, 173, 34541, 34712, 34539, 93, 120, 5007, 67, 35317, 32513, 34535, 5009, 35320, 239, 147, 5018, 5027, 51, 35332, 35323, 35336, 27, 87, 84, 36588, 36521, 35720, 36590, 35718, 87, 5040, 35346, 36591, 81, 5078, 36594, 5071, 124, 5040, 75, 5056, 5161, 120, 5117, 5039, 5074, 5071, 50, 5080, 19, 5129, 5190, 5197, 503, 101, 167, 5112, 5123, 5576, 5571, 5511, 1058, 1101, 5583, 1092, 57, 61, 5582, 81, 36569, 49, 98, 102, 5586, 81, 80, 85, 109, 88, 107, 104, 106, 70, 77, 79, 72, 66, 51, 108, 78, 114, 36573, 116, 114, 122, 95, 5602, 1258, 1599, 36538, 133, 132, 48, 5608, 25498, 36617, 42, 1190, 13, 137, 8, 136, 1086, 105, 3, 29, 5384, 5038, 132, 140, 5499, 141.

US Nationwide Distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OK, OH, PA, PR, RI, SC, TN, TX, VA, VT, WA, WI, and WV; and the countries of: Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Monaco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam, and Yemen.

Voluntary: Firm initiated