{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183838", "product_res_number": "Z-0126-2021", "event_date_initiated": "2020-09-14", "event_date_created": "2020-10-20", "recall_status": "Terminated", "event_date_terminated": "2023-08-14", "res_event_number": "86501", "product_code": "MOS", "k_numbers": [ "K033567", "K053017", "K103149", "K162001" ], "product_description": "MR Coils\n\nThe 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.", "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, 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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.", "firm_fei_number": "1000113495", "recalling_firm": "Invivo Corporation", "address_1": "3545 SW 47th Ave", "city": "Gainesville", "state": "FL", "postal_code": "32608-7691", "additional_info_contact": "Michael Voss\n352-336-0010", "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_description": "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.\nAlthough 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:\n-Notify all members of your staff who need to be aware of the contents of this communication.\n-Complete and e-mail the Acknowledgement Form included in this letter.\nemail completed form to: DL_CHU_Invivo@philips.com\n-Immediate corrections are taking place to remove IPX1 symbols from labels for future use.\n\nA Ship Hold and Market Hold were placed on the product in order to contain affected product not yet shipped. \n\nIf 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)", "product_quantity": "12,764 units", "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.", "openfda": { 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