MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner t...
FDA Device Recall #Z-0126-2021 — Class III — September 14, 2020
Recall Summary
| Recall Number | Z-0126-2021 |
| Classification | Class III — Low risk |
| Date Initiated | September 14, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Invivo Corporation |
| Location | Gainesville, FL |
| Product Type | Devices |
| Quantity | 12,764 units |
Product Description
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.
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.
Distribution Pattern
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.
Lot / Code Information
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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Other Recalls from Invivo Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1440-2020 | Class II | Monitor for the Functional Imaging System for M... | Feb 6, 2020 |
| Z-0462-2019 | Class II | Xper Flex Cardio Physiomonitoring System, Softw... | Sep 24, 2018 |
| Z-3192-2018 | Class II | Xper Flex Cardio Physiomonitoring System Model ... | Aug 3, 2018 |
| Z-1867-2018 | Class II | PHILIPS Xper Flex Cardio Physiomonitoring Syste... | Mar 14, 2018 |
| Z-1289-2018 | Class II | DynaCad software consist of an MR Analysis Serv... | Jan 24, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.