510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0126-2021Class III

MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce...

Invivo Corporation / initiated 2020-09-14 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Invivo Corporation began a recall of 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... on . FDA classified it as Class III and gives the reason as "The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0126-2021
Classification
Class III
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invivo Corporation
Product
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.
Product code
MOS Coil, Magnetic Resonance, Specialty
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.
Root cause tag
labeling and UDI
FDA root cause
Labeling Change Control
Action
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: [email protected] -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)
Quantity in commerce
12,764 units
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.
Product codes and lots
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, 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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, 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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, 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141.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0126-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0126-2021Class IIITerminatedVoluntary: Firm initiated