{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "142441", "product_res_number": "Z-0553-2016", "event_date_initiated": "2015-12-07", "event_date_posted": "2015-12-28", "recall_status": "Terminated", "event_date_terminated": "2018-11-08", "res_event_number": "72892", "product_code": "MOS", "k_numbers": [ "K110610" ], "product_description": "GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS.\n\nProduct Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.", "code_info": "Mfg Lot or Serial #\tSystem ID 00000001140049\tBMDACCMR1 00000001140050\tBMDACCMR1 0000011-4-0050\tBMDACCMR1 0000011-4-0009\t920568MR3T 0000011-4-0015\t920568MR3T 0000011-4-0017\t602406IMR 0000011-4-0018\t602406IMR 0000011-4-0024\t602406IMR 0000014-4-0007\t602406IMR 0000011-4-0028\t626359MR3 0000011-4-0032\t626359MR3 0000011-4-0046\tMSK68MR4 0000011-4-0047\tMSK68MR4 0000028-3-0011\tMSK68MR4 0000044-4-0046\tMSK68MR4 0000011-4-0064\t415CB3TW 0000011-4-0065\t415CB3TW 0000011-4-0066\t415723SHAW12 0000011-4-0067\t415723SHAW12 0000011-4-0075\t616267IMRI 0000011-4-0076\t616267IMRI 011-4-0085\t616267IMRI 011-4-0170\t616267IMRI 0000011-4-0094\t330344MR750W 011-4-0118\t330344MR750W 0000011-4-0101\t713792CMR1 0000011-4-0102\t713792CMR1 0000011-4-0107\t317887MR3 0000011-4-0108\t317887MR3 0000011-4-0114\t309655MR750W 0000011-4-0115\t309655MR750W 011-4-0117\t517353DVMR 011-4-0172\t517353DVMR 011-4-0119\t614293MR9 011-4-0120\t614293MR9 011-4-0124\tMR229050 077-4-0123\tMR229050 011-4-0125\t6053223TMR 011-4-0126\t6053223TMR 011-4-0129\t6053223TMR 011-4-0130\t6053223TMR 011-4-0146\t480342MR3 011-4-0149\t480342MR3 011-4-0154\t773665SJMR2 011-4-0155\t773665SJMR2 011-4-0162\t720848MR4 011-4-0164\t720848MR4 0000011-4-0055\t415723SCHMR2 0000011-4-0062\t405271OUCMR 0000011-4-0080\t847872ZMR2 0000011-4-0106\t949760MR3 011-4-0169\t415UCBHMR3 MISSING_SN_GON4217108\t408358SHMR13 Missing_SN_GON4227287\t309655IMRI 0000011-4-0019\t416369MR3T 0000011-4-0020\t416369MR3T 011-4-0128\tE416249MR2 11-4-0127\tE416249MR2 0000011-4-0027\t082427040101 0000011-4-0033\t082427040101 0000011-4-0133\t082427040167 0000011-4-0134\t082427040167 0000011-4-0086\tCS1006MR03 0000011-4-0092\tCS1006MR03 0000011-4-0153\tCS1006MR03 0000011-4-0158\tA5547422 0000011-4-0159\tA5547422 0000011-4-0103\tEM0229 0000011-4-0104\tEM0229 0000011-4-0156\tEM0276 0000011-4-0157\tEM0276 0000011-4-0165\tEM0276 0000011-4-0166\tEM0276 0000028-4-0016\tRTD0191 0000011-4-0060\tRTD0191 0000011-4-0061\tRTD0191 0000011-4-0093\t0920279024 0000011-4-0098\t0920279024 0000011-4-0034\tPER08626 0000011-4-0035\tPER08626 0000011-4-0056\tRO1098MR02 0000011-4-0057\tRO1098MR02 0000011-4-0030\tZA2169MR01 0000011-4-0031\tZA2169MR01 0000011-4-0042\t690120MR01 0000011-4-0043\t690120MR01 0000011-4-0044\t786090MR06 0000011-4-0045\t786090MR06 0000011-4-0143\t06162MRS01 0000011-4-0144\t06162MRS01", "firm_fei_number": "2183553", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3200 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1693", "additional_info_contact": "GE Healthcare Service\n262-521-6560", "reason_for_recall": "Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.", "root_cause_description": "Nonconforming Material/Component", "action": "Consignees were sent on 12/7/2015 a GE Healthcare \"Urgent Medical Device Correction\" GEHC Ref#60888 letter dated December 7, 2015. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.\n\nUPDATE: Consignees were sent a revised letter on May 2, 2016. Previously the letter only listed MR750W Surgical Suite Scanners. Because 3.0T 6 Channel Flex Coils are used with the MR750, MR750W, and 3.0T HDxT (including HD23), these devices have been added to the letter. There are no other changes to the letter.\n\nUPDATE 5/27/16: Consignees were sent a revised letter on May 19, 2016. The letter topic stated \"De-rating of 3.0T 6 Channel Flex Coil when used on Discovery MR750 running DV24, DV25, or DV25.1 Application Software\" . The letter described the Safety Issue, Safety Instruction, Affected Product details, Product Correction and Contact Information (same as previous letter).", "product_quantity": "90 (54 US; 36 OUS)", "distribution_pattern": "Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, WI, DC, PR and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWITZERLAND, TURKEY, SWEDEN, AUSTRALIA, BRAZIL, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, ITALY, MEXICO, RUSSIA, SAUDI ARABIA, TAIWAN, UNITED KINGDOM, INDONESIA, ESTONIA, REPUBLIC OF KOREA, POLAND, KUWAIT, SPAIN.", "openfda": { "k_number": [ "K113365", "K162863", "K023679", "K993776", "K171515", "K172695", "K183186", "K061950", "K093842", "K000589", "K971246", "K010946", "K213735", "K972340", "K002483", "K212864", "K222325", "K971016", "K070778", "K991765", "K071311", "K061281", "K163066", "K173290", "K973787", "K013810", "K113474", "K991113", "K001312", "K123492", "K011683", "K022487", "K013099", "K010513", "K982919", "K001946", "K052704", "K983139", "K172222", "K000345", "K033292", "K033490", "K223487", "K231647", "K061952", "K182737", "K062767", "K993235", "K013595", "K083160", "K983109", "K000002", "K100141", "K223239", "K081322", "K072931", "K032633", "K262294", "K052827", "K090267", "K113280", "K973630", "K112293", "K103335", "K051763", "K093284", "K033152", "K070629", "K053042", "K011781", "K964668", "K050307", "K242096", "K013159", "K050299", "K030540", "K102889", "K050728", "K023848", "K050621", "K051618", "K040937", "K031095", "K021751", "K001713", "K133506", "K183111", "K001209", "K093667", "K021433", "K982978", "K122897", "K032045", "K003144", "K100670", "K992650", "K093693", "K022720", "K981406", "K022007", "K955626", "K103274", "K133422", "K080120", "K232021", "K252587", "K021330", "K213351", "K020850", "K964813", "K032474", "K013528", "K103149", "K093689", "K042844", "K061715", "K020036", "K141832", "K080820", "K162651", "K964678", "K052585", "K110487", "K083014", "K982916", "K083578", "K211658", "K041487", "K152695", "K160932", "K103506", "K022372", "K002774", "K991740", "K103365", "K243428", "K223429", "K213687", "K162177", "K023164", "K023571", "K160935", "K120290", "K182504", "K012491", "K071611", "K052045", "K024352", "K020495", "K030953", "K111251", "K031139", "K072873", "K193140", "K000437", "K001944", "K993819", "K102348", "K003097", "K083434", "K101858", "K163205", "K024209", "K162029", "K161193", "K954190", "K052584", "K964854", "K950966", "K022488", "K963356", "K111802", "K001097", "K123708", "K233348", "K003655", "K111259", "K013322", "K072935", "K031089", "K032415", "K151829", "K032429", "K032538", "K042186", "K000935", "K020606", "K071882", "K072874", "K060758", "K983143", "K222257", "K040122", "K071966", "K254190", "K991115", "K212239", "K992193", "K013594", "K121911", "K022395", "K081340", "K103275", "K013592", "K023084", "K984272", "K243316", "K002345", "K182958", "K051512", "K002539", "K233600", "K123681", "K993477", "K964820", "K022910", "K021575", "K060689", "K040348", "K050476", "K010802", "K041921", "K972205", "K121910", "K093348", "K001303", "K073181", "K262330", "K022582", "K003340", "K111673", "K023982", "K953595", "K132444", "K031209", "K994042", "K081745", "K980157", "K062556", "K000993", "K142676", "K982339", "K984588", "K013985", "K022669", "K083539", "K122694", "K982496", "K252876", "K982972", "K083166", "K223225", "K151753", "K112366", "K143389", "K052077", "K101632", "K023596", "K071847", "K173377", "K060547", "K220144", "K001582", "K100113", "K031536", "K142755", "K972296", "K042103", "K000549", "K191539", "K243675", "K012728", "K002482", "K101492", "K200836", "K013508", "K020601", "K073131", "K112112", "K080062", "K061170", "K081198", "K001870", "K961391", "K052916", "K232762", "K993898", "K063513", "K083255", "K142002", "K182590", "K101949", "K023650", "K123272", "K123091", "K040349", "K162623", "K994040", "K031366", "K033662", "K110411", "K984159", "K083086", "K253182", "K031365", "K241069", "K201101", "K971667", "K050622", "K112002", "K993780", "K961525", "K110373", "K031172", "K142802", "K030495", "K063342", "K233656", "K213480", "K982772", "K023929", "K162966", "K071534", "K162946", "K200477", "K020993", "K173446", "K984278", "K041481", "K103342", "K001331", "K010730", "K013514", "K042718", "K991724", "K972592", "K072909", "K993233", "K073236", "K003386", "K091902", "K091047", "K130706", "K031143", "K060873", "K042009", "K120122", "K013602", "K253738", "K092962", "K163661", "K133986", "K024208", "K003366", "K180666", "K040640", "K082916", "K190668", "K024187", "K993719", "K150331", "K140998", "K981959", "K002916", "K994315", "K140282", "K110610", "K032090", "K231085", "K961628", "K023247", "K033353", "K181948", "K022588", "K014086", "K052497", "K002522", "K110120", "K980691", "K122638", "K112313", "K001210", "K032618", "K091114", "K031056", "K030042", "K042617", "K003685", "K063373", "K103185", "K041185", "K993279", "K223484", "K974308", "K121362", "K023442", "K954952", "K213397", "K060401", "K020790", "K052621", "K233444", "K022863", "K243033", "K052200", "K990007", "K983222", "K964141", "K010140", "K041145", "K994436", "K082636", "K140252", "K981094", "K033235", "K260519", "K021262", "K003946", "K121249", "K082987", "K994378", "K033567", "K021141", "K233652", "K162079", "K173469", "K021570", "K110591", "K091546", "K102748", "K223378", "K022883", "K140606", "K984257", "K053017", "K013894", "K030317", "K042342", "K073310", "K050514", "K011608", "K013541", "K991057", "K964969", "K242879", "K040288", "K970868", "K002860", "K123327", "K083541", "K010074", "K991434", "K033151", "K974438", "K111060", "K002864", "K012353", "K051349", "K162001", "K003505", "K180123", "K013854", "K032576", "K252179", "K222407", "K042207", "K030371", "K003331", "K033753", "K122646", "K151653", "K003613", "K021631", "K982921", "K244054", "K120627", "K081118", "K994345", "K181697", "K031119", "K003436", "K082373", "K002602", "K260947", "K071179", "K130457", "K213766", "K213727", "K024354", "K952944" ], "registration_number": [ "", "3002808157", "3010326005", "3011950073", "3018423337", "1529041", "3015431711", "9616047", "3012761544", "1043549", "2183553", "3031503890", "3008632256", "3014809646", "3011015597", "3008284470", "3023003446", "2011171", "3010703925", "3026047529", "3012085143", "3029521953", "3014343100", "3036666444", "3035950510", "1054811", "3008986341", "3003768277", "3021244844", "3006239787", "3012439308", "3005049692", "3004531751", "1835830", "3021059265", "3009755250", "3005877899", "2029275", "3009514037", "3000126629", "3006369484", "3017375271", "3027339477", "3009196578", "3010949642", "3009529630", "3009077524", "3009963139", "3004754211", "3004977335", "3013875850", "3007350713", "3015329423", "3028006458", "3005326970", "3032109225", "3009970070", "3014310698", "3014635027", "3012169560", "3016851825", "3006262888", "3042177665", "3007137598", "9613936", "3009656988", "9614698", "3008414621", "3010132318", "1932898", "2183744", "1058584", "3015276088", "3007562060", "3004929307", "3009714754", "3008355361" ], "fei_number": [ "", "3002808157", "3010326005", "3011950073", "3018423337", "3015431711", "1000306431", "3012761544", "1043549", "2183553", "3031503890", "3008632256", "3014809646", "3011015597", "3008284470", "3005214683", "3023003446", "2011171", "3010703925", "3026047529", "3012085143", "3029521953", "3014343100", "3036666444", "3035950510", "3008986341", "3021244844", "3006239787", "3012439308", "1000114185", "3005049692", "3004531751", "1000571342", "1000219637", "3021059265", "3009755250", "3005877899", "3002808382", "1000158431", "3009514037", "3000126629", "3006369484", "3017375271", "3003377038", "3027339477", "3009196578", "3010949642", "3009529630", "3009077524", "3009963139", "3004754211", "3004977335", "3013875850", "3007350713", "3015329423", "3028006458", "3005326970", "3032109225", "3009970070", "3014310698", "3014635027", "3012169560", "3002807880", "3016851825", "3006262888", "3042177665", "3007137598", "3009656988", "3008414621", "3010132318", "3001814065", "2183744", "3015276088", "3007562060", "3004929307", "3009714754", "3008355361" ], "device_name": "Coil, Magnetic Resonance, Specialty", "medical_specialty_description": "Radiology", "regulation_number": "892.1000", "device_class": "2" } } ] }