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.
This recall has been terminated (originally issued September 14, 2020).
- Company
- Invivo Corporation
- Recall Initiated
- September 14, 2020
- Terminated
- August 14, 2023
- Recall Number
- Z-0126-2021
- Quantity
- 12,764 units
- Firm Location
- Gainesville, FL
- Official Source
- View on FDA website ↗
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
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 Info
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.
Root Cause
Labeling Change Control
Action Taken
The firm, Philips Invivo, an " URGENT - Field Safety Notice" dated 9/14/20 to its customers. The notice described the product, problem and actions to be taken. Although the symbol on the label should not be have been included, the device poses no risk to users of these devices nor patients. Customers need take no action other than the following: -Notify all members of your staff who need to be aware of the contents of this communication. -Complete and e-mail the Acknowledgement Form included in this letter. email completed form to: DL_CHU_Invivo@philips.com -Immediate corrections are taking place to remove IPX1 symbols from labels for future use. A Ship Hold and Market Hold were placed on the product in order to contain affected product not yet shipped. If you need any further information or support concerning this issue, please contact your local Philips representative: North America: 1-877-Invivo-1 option 3 (1-877-468-4861, option #3)