CLASS III Device recall · Reported 28 Oct 2020 · FDA Enforcement Report

MR Coils The MR Coil is intended to be used recalled by Invivo

Invivo is recalling MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance, distributed nationwide in the US. The recall was initiated on 14 Sep 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModels: 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, 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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, 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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.

Quantity recalled12,764 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0126-2021
FDA event ID: 86501
Recalling firm: Invivo, Gainesville, FL
Classification: Class III
Status: Terminated
Recall initiated: 14 Sep 2020
FDA classified: 19 Oct 2020
Reported: 28 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

14 Sep 2020	Recall initiated by company
19 Oct 2020	Classified by FDA	+35 days
28 Oct 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Colorado Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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, 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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, 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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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Invivo

All 18

Reported	Class	Recall	Company	Reason	Where
11 Mar 2020Device	CLASS II	Monitor for the Functional Imaging System recalled by Invivo	Invivo	Other	17 states
21 Nov 2018Device	CLASS II	Xper Flex Cardio Physiomonitoring System recalled by Invivo	Invivo	Device Malfunction	FL
26 Sep 2018Device	CLASS II	Xper Flex Cardio Physiomonitoring System recalled by Invivo	Invivo	Labeling Errors	FL
13 Jun 2018Device	CLASS II	Xper Flex Cardio Physiomonitoring System The Xper Flex recalled	Invivo	Temperature Abuse	Nationwide
11 Apr 2018Device	CLASS II	DynaCad software consist of an MR Analysis Server software recalled	Invivo	Device Malfunction	FL

Other Test Kits & Diagnostics recalls

All 2,658

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled	Biomerieux	Other	MO
23 Sep 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	STA Staclot Protein recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide