{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167258", "product_res_number": "Z-0199-2019", "event_date_initiated": "2018-05-30", "event_date_created": "2018-10-22", "recall_status": "Open, Classified", "res_event_number": "81026", "product_code": "LNH", "k_numbers": [ "K120638", "K170412", "K171597" ], "product_description": "Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.", "code_info": "MODEL SERIAL NUMBER SID MEXL-1504/U4\tU4A12Z2020\t30005914 MEXL-1504/T4\tS4D1132069\t339325 MEXL-1504/S4\tS4A1032017\t326165 MEXL-1504/U4\tU4A1312023\t30000547 MEXL-1504/S4\tS4A1032019\t327601 MEXL-1504/U4\tU4A1312024\t30002325 MEXL-1504/T4\tS4D1152082\t330035 MEXL-1504/S4\tS4A1082040\t330134 MEXL-1504/A4\tA4A11Z2011\t346866 MEXL-1504/U4\tU4A1282003\t356105 MEXL-1504/U4\tU4A1322025\t30009003 MEXL-1504/U4\tU4B1442070\t30012516 MEXL-1504/U4\tU4A1352035\t389636 MEXL-1504/U4\tU4B1552097\t30010318 MEXL-1504/U4\tU4A12X2010\t351817 MEXL-1504/S4\tS4C1112065\t330381 MEXL-1504/S4\tS4C1112064\t334599 MEXL-1504/A4\tA4A11Z2009\t352039 MEXL-1504/S4.004\tS4A1072033\t30025756 MEXL-1504/S4\tS4A09Y2002\t345231 MEXL-1504/U4.004\tU4A1282002\t30027784 MEXL-1504/U4.004\tU4A1382047\t30036224 MEXL-1504/S3\tS3A0972030\t312421 MEXL-1504/U4\tU4A12X2011\t345074 MEXL-1504/S4\tS4C1112061\t337212 MEXL-1504/U4\tU4A13X2054\t30011038 MEXL-1504/A4\tA4A1222015\t351023 MEXL-1504/U4\tU4A1322026\t337071 MEXL-1504/U4\tU4B1642106\t30008395 MEXL-1504/A4\tA4A1222017\t347963 MEXL-1504/S4\tS4A10X2047\t315713 MEXL-1504/S3\tS3A08Z2019\t303586 MEXL-1504/U4\tU4B1522092\t358163 MEXL-1504/A4\tA4A11X2004\t30018147 MEXL-1504/T4\tS4D1132074\t347260 MEXL-1504/U4\tU4B1422064\t30021502 MEXL-1504/U4\tU4A1312022\t30004266 MEXL-1504/U4\tU4A1352036\t30001882 MEXL-1504/U4\tU4A1372046\t337083 MEXL-1504/T4\tS4D1142076\t341529 MEXL-1504/U4\tU4A13Z2057\t30005810 MEXL-1504/A4\tA4A11Z2010\t349167 MEXL-1504/U4\tU4A1292007\t349175 MEXL-1504/U4\tU4B1632105\t366015 MEXL-1504/U4\tU4B1492081\t376523 MEXL-1504/U4\tU4A1352037\t389696 MEXL-1504/U4\tU4A1312021\t353532 MEXL-1504/U4\tU4B1482077\t392326 MEXL-1504/A4\tA4A11X2002\t333633 MEXL-1504/U4\tU4B14Y2082\t30018555 MEXL-1504/U4\tU4A13X2051\t325434 MEXL-1504/A4\tA4A11Y2006\t350868 MEXL-1504/A4\tA4A1252024\t356295 MEXL-1504/U4\tU4B1532094\t30027785 MEXL-1504/U4\tU4B1652107\t30009792 MEXL-1504/S3\tS3A0922023\t299545 MEXL-1504/U4\tU4A1382049\t30007016 MEXL-1504/U4\tU4A12Z2014\t356808 MEXL-1504/S3\tS3A0892009\t301747 MEXL-1504/A4\tA4A11X2003\t324905 MEXL-1504/S3.004\tS3A0882007\t30024991 MEXL-1504/T4\tS4D1132073\t339838 MEXL-1504/U4\tU4A1362039\t393723 MEXL-1504/U4\tU4B1462074\t356287 MEXL-1504/U4\tU4B1522091\t30006245 MEXL-1504/U4\tU4A1342033\t30004737 MEXL-1504/U4\tU4A1342034\t30001465 MEXL-1504/U4\tU4A12X2009\t354860 MEXL-1504/U4\tU4A1412059\t383292 MEXL-1504/U4\tU4A1412063\t30003291 MEXL-1504/U4\tU4A1282004\t356881 MEXL-1504/U4\tU4A1352038\t30004544 MEXL-1504/U4\tU4A12Y2013\t359834 MEXL-1504/U4\tU4B14Z2086\t30023668 MEXL-1504/U4\tU1A13Z2001\t30007654 MEXL-1504/S3\tS3A0942027\t314575 MEXL-1504/U4\tU4A1272001\t357343 MEXL-1504/U4\tU4A1292006\t384206 MEXL-1504/S4\tS4A1042023\t308445 MEXL-1504/S3\tS3A08Z2016\t308437 MEXL-1504/A4\tA4A11X2001\t342766 MEXL-1504/U4\tU4B1512089\t30006322 MEXL-1504/A4\tA4A1212012\t352641 MEXL-1504/U4\tU4A1342029\t314591 MEXL-1504/T4\tS4E1192095\t340919 MEXL-1504/U4\tU4A1362041\t30004910 MEXL-1504/U4\tU4A12Y2012\t356816 MEXL-1504/U4\tU4A1382050\t30006997 MEXL-1504/A4\tA4A1242021\t345363 MEXL-1504/S4\tS4A1092046\t333104 MEXL-1504/A4\tA4A1252023\t348078 MEXL-1504/U4\tU4B15Y2102\t30002102 MEXL-1504/U5\tU5B15Z2001\t30002103 MEXL-1504/T4\tS4D1132071\t328690 MEXL-1504/U4\tU4A13Y2056\t30004937 MEXL-1504/S4\tS4A1092043\t310631 MEXL-1504/U4\tU4A1322027\t394526 MEXL-1504/U4\tU4B1522093\t30007522 MEXL-1504/U4\tU4A1412061\t389344 MEXL-1504/S3\tS3A0872005\t298422 MEXL-1504/U4\tU4A12Z2017\t357400 MEXL-1504/A4\tA4A1212013\t349118 MEXL-1504/U4\tU4B1482076\t30020797 MEXL-1504/U4\tU4B1552098\t30012104 MEXL-1504/A4\tA4A1222019\t352146 MEXL-1504/S4\tS4A1052025\t324327 MEXL-1504/U4\tU4A1292008\t356568 MEXL-1504/A4\tA4A1222016\t340950 MEXL-1504/U4\tU4B1432067\t30007279 MEXL-1504/U4\tU4A1362042\t357418 MEXL-1504/S4\tS4A1092045\t333047 MEXL-1504/U4\tU4B1452071\t30009112 MEXL-1504/A4\tA4A1242022\t351429 MEXL-1504/A4\tA4A1262025\t394677 MEXL-1504/S4\tS4A1082036\t331306 MEXL-1504/S4\tS4C1112060\t340539 MEXL-1504/T4\tS4D1152081\t342436 MEXL-1504/S4\tS4A09X2001\t317842 MEXL-1504/U4\tU4A12Z2019\t356063 MEXL-1504/T4.004\tS4D1142079\t372281 MEXL-1504/U4\tU4B1512090\t30011831 MEXL-1504/U4\tU4A13X2055\t372615 MEXL-1504/U4\tU4A1362044\t30008519 MEXL-1504/A4\tA4A11X2005\t343723 MEXL-1504/U4\tU4B15X2101\t30008684 MEXL-1504/S4\tS4A1072032\t316471 MEXL-1504/U4\tU4B1482079\t377483 MEXL-1504/U4\tU4B1582100\t30004842 MEXL-1504/S4\tS4A1022013\t313254 MEXL-1504/S4\tS4A1022014\t313262 MEXL-1504/U4\tU4B1612103\t30029397 MEXL-1504/T4\tS4D1132070\t337303 MEXL-1504/U4\tU4A1382048\t30003156 MEXL-1504/U4\tU4B1612104\t385256 MEXL-1504/T4\tS4E1182093\t342311 MEXL-1504/U4\tU4A13X2052\t380285 MEXL-1504/U4\tU4A12Z2015\t356840 MEXL-1504/U4\tU4B1452072\t369092 MEXL-1504/U4\tU4B1452073\t30007850 MEXL-1504/U4\tU4B1582099\t30006070 MEXL-1504/S4\tS4A1022015\t326512 MEXL-1504/U4\tU4B14Y2084\t365309 MEXL-1504/S3\tS3A08Y2013\t292490 MEXL-1504/S4\tS4B10Z2058\t336701 MEXL-1504/S3\tS3A09X2039\t351542 MEXL-1504/S4\tS4A1092044\t308189 MEXL-1504/A4\tA4A1222018\t345587 MEXL-1504/A4.007\tA4A1222014\t392554 MEXL-1504/T4\tS4D1172089\t345140 MEXL-1504/U4\tU4B1432066\t30008575 MEXL-1504/U4\tU4B1442069\t30007942 MEXL-1504/S4\tS4A1082041\t329656 MEXL-1504/S3\tS3A09X2041\t311514 MEXL-1504/A4\tA4A11Y2008\t348169 MEXL-1504/S3\tS3A08Y2012\t311506 MEXL-1504/S4\tS4A1062030\t311522 MEXL-1504/S3\tS3A0992038\t304907 MEXL-1504/U4\tU4B1472075\t348151 MEXL-1504/S3\tS3A09X2040\t MEXL-1504/S4\tS4A1042022\t326355 MEXL-1504/U4\tU4B1512087\t30009776 MEXL-1504/T4\tS4D1162086\t344267 MEXL-1504/U4\tU4A1342031\t351320 MEXL-1504/U4\tU4A1342032\t30005999 MEXL-1504/U4\tU4A1362040\t30007243 MEXL-1504/S4\tS4B10Y2053\t334979 MEXL-1504/S4\tS4C1112066\t337048 MEXL-1504/U4\tU4A12Z2016\t394744 MEXL-1504/S3\tS3A0972031\t299453 MEXL-1504/U4\tU4A1282005\t30003217 MEXL-1504/U4\tU4B1512088\t30027396 MEXL-1504/S4\tS4A1052026\t336677 MEXL-1504/S4\tS4A1012011\t299271 MEXL-1504/U4\tU4B14Z2085\t30020944 MEXL-1504/U4\tU4A1332028\t30002698 MEXL-1504/U4\tU4A13X2053\t30008346 MEXL-1504/U4\tU4B1442068\t30008347 MEXL-1504/U4\tU4A1412060\t30008348 MEXL-1504/U4\tU4A1362045\t30008837 MEXL-1504/U4\tU4B14Y2083\t30008842 MEXL-1504/U4\tU4B1482078\t30010457 MEXL-1504/U4\tU4B1422065\t350207 MEXL-1504/U4\tU4A1342030\t362189 MEXL-1504/S4\tS4A09Y2003\t306985 MEXL-1504/U4\tU4B1492080\t30002625 MEXL-1504/S3\tS3A0992036\t307538 MEXL-1504/U4\tU4B1542095\t391411 MEXL-1504/U4\tU4B1542096\t380834 MEXL-1504/U4\tU4A1412062\t366506 MEXL-1504/S4\tS4A1012009\t308056 MEXL-1504/U4.004\tU4A1282002\t30027784 MEXL-1504/U4.004\tU4A1382047\t30036224 MRT-1504/S4\tS4A1052027\t330217 MEXL-1504/U4.004\tU4A12Z2018\t MEXL-1504/U4.004\tU4A1362043\t MEXL-1504/U4.004\tU4A12Z2018\t MEXL-1504/U4.004\tU4A1362043  Model MEXL-1510 MEXL-1510/S2\tS2B1642037 MEXL-1510/S2\tS2A15Y2019 MEXL-1510/S2/E\tS2B16Y2055 MEXL-1510/S2\tS2B1652041 MEXL-1510/S2\tS2C1762072 MEXL-1510/S3\tS3A16Z2007 MEXL-1510/S2/E\tS2C1772077 MEXL-1510/S2\tS2A1592013 MEXL-1510/S3\tS3B1782012 MEXL-1510/S2\tS2A1612025 MEXL-1510/S2/E\tS2B1692050 MEXL-1510/S3\tS3A1692003 MEXL-1510/S2/E\tS2C1772075 MEXL-1510/S3\tS3B17Y2016 MEXL-1510/S2\tS2A15Z2023 MEXL-1510/S2\tS2A15Y2018 MEXL-1510/S2/E\tS2C1772074 MEXL-1510/S2\tS2C1782081 MEXL-1510/S3\tS3B1762010 MEXL-1510/S2\tS2C1762071 MEXL-1510/S3\tS3B1762009 MEXL-1510/S2\tS2C1782082 MEXL-1510/S2\tS2B1632035 MEXL-1510/S2/E\tS2D1812097 MEXL-1510/S2\tS2A1582010 MEXL-1510/S2/E\tS2B16Z2061 MEXL-1510/S2/E\tS2B1732065 MEXL-1510/S2\tS2B1632036 MEXL-1510/S2\tS2B1672045 MEXL-1510/S3\tS3B17X2015 MEXL-1510/S2\tS2B1632030 MEXL-1510/S3\tS3A16Z2006 MEXL-1510/S2/E\tS2B1642040 MEXL-1510/S2\tS2A1612024 MEXL-1510/S2\tS2C1752070 MEXL-1510/S2/E\tS2C1772076 MEXL-1510/S2\tS2B1692048 MEXL-1510/S2\tS2B1692049 MEXL-1510/S2\tS2A1572008 MEXL-1510/S2\tS2B1622029 MEXL-1510/S2\tS2A1582012 MEXL-1510/S3\tS3A16Y2004 MEXL-1510/S2/E\tS2B16X2054 MEXL-1510/S3\tS3B1782013 MEXL-1510/S2\tS2A15Y2016 MEXL-1510/S2\tS2B1642039 MEXL-1510/S2\tS2B16Y2058 MEXL-1510/S2\tS2B1632031 MEXL-1510/S2/E\tS2C17Y2093 MEXL-1510/S2\tS2C1772078 MEXL-1510/S3\tS3B1772011 MEXL-1510/S3\tS3A16Z2005 MEXL-1510/S3\tS3B1782014 MEXL-1510/S2\tS2B16Z2060 MEXL-1510/S2\tS2A1562006 MEXL-1510/S2\tS2A15Z2021 MEXL-1510/S2/E\tS2C1772079 MEXL-1510/S2\tS2A1552005 MEXL-1510/S2\tS2A1612026 MEXL-1510/S2/E\tS2C17Y2090 MEXL-1510/S2\tS2D1822098 MEXL-1510/S2\tS2D1832101 MEXL-1510/S3\tS3C1812017 MEXL-1510/S3\tS3C1832018  Model MEXL-1520 MEXL-1520/S1\tS1C1672334\t30032698 MEXL-1520/S1\tS1C1682336\t30035150 MEXL-1520/S1\tS1C1722390\t30040716 MEXL-1520/S1\tS1D17Y2461\t30036289 MEXL-1520/S1\tS1B1492068\t70000226", "firm_fei_number": "2020563", "recalling_firm": "Canon Medical System, USA, INC.", "address_1": "2441 Michelle Dr", "city": "Tustin", "state": "CA", "postal_code": "92780-7047", "additional_info_contact": "Terry Schultz\n714-730-5000", "reason_for_recall": "When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.", "root_cause_description": "Device Design", "action": "On 05/20/2018 the firm sent an Urgent Medical Device Correction letter to customers via United States Postal Service return receipt mail informing them that when a user used the respiratory gating with Steady Mode ON in Spin Echo\nsequence scan, the SAR value displayed on console was lower than the actual SAR value because there was a wrong estimating the RF pulses in the software.\n\nThe SAR may exceed the upper limit, when a user scans a patient near the upper limit of the first level controlled operating mode in case of using the respiratory gating with Steady Mode ON in Spin Echo sequence scan. That may cause a burn of a patient.\n\nApplicable System/Model:\n-MEXL-1504/MEXL-1510: Vantage Titan\n-MEXL-1520: Vantage Elan\n\nCorrective Action:\nModified system software to correct this issue will be installed on your system. When the software becomes available, your Canon service representative will contact your for an appointment to schedule the installation.\n\nRequest to Customers:\nUntil the modification is completed on your system, do not use Spin Echo sequences when using respiratory gating with Steady Mode ON. If you wish to use respiratory gating with Steady Mode ON, use Fast Spin Echo sequences.\nPlease share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility.\n\nCustomers are instructed to please complete the attached form and fax it to the toll-free number shown at the top of the form. This form can also be sent via email to RAffairs@us.medical.canon.\n\nIf you have any questions, please feel free to contact Regulatory Affairs at (800) 421-1968 or your local service representative at (800) 521-1968.", "product_quantity": "252", "distribution_pattern": "Domestic: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WI, WV, and WY.\n\nInternational: Algeria, Australia, Bangladesh, Brazil, Canada, China, Colombia, Congo, Dominican Republic, Egypt, Guinea, Honduras, India, Indonesia, Iran, Japan, Kenya, Korea, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Nigeria, Oman, Pakistan, Paraguay, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, Turkey, UAE, and Vietnam", "openfda": { "k_number": [ "K241607", "K063559", "K944469", "K901620", "K170090", "K213305", "K893881", "K121160", "K961366", "K891760", "K980645", "K960497", "K220332", "K932375", 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