Class 2 Device Recall Vantage Titan/Titan 1.5T MRI MPower GX and Vantage Elan 1.5T V4.0 MRI

• Date Initiated by Firm: May 30, 2018
• Create Date: October 22, 2018
• Recall Status: Open, Classified
• Recall Number: Z-0199-2019
• Recall Event ID: 81026
• 510(K)Number: K120638 K170412 K171597
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: 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 Information: MODEL SERIAL NUMBER SID MEXL-1504/U4 U4A12Z2020 30005914 MEXL-1504/T4 S4D1132069 339325 MEXL-1504/S4 S4A1032017 326165 MEXL-1504/U4 U4A1312023 30000547 MEXL-1504/S4 S4A1032019 327601 MEXL-1504/U4 U4A1312024 30002325 MEXL-1504/T4 S4D1152082 330035 MEXL-1504/S4 S4A1082040 330134 MEXL-1504/A4 A4A11Z2011 346866 MEXL-1504/U4 U4A1282003 356105 MEXL-1504/U4 U4A1322025 30009003 MEXL-1504/U4 U4B1442070 30012516 MEXL-1504/U4 U4A1352035 389636 MEXL-1504/U4 U4B1552097 30010318 MEXL-1504/U4 U4A12X2010 351817 MEXL-1504/S4 S4C1112065 330381 MEXL-1504/S4 S4C1112064 334599 MEXL-1504/A4 A4A11Z2009 352039 MEXL-1504/S4.004 S4A1072033 30025756 MEXL-1504/S4 S4A09Y2002 345231 MEXL-1504/U4.004 U4A1282002 30027784 MEXL-1504/U4.004 U4A1382047 30036224 MEXL-1504/S3 S3A0972030 312421 MEXL-1504/U4 U4A12X2011 345074 MEXL-1504/S4 S4C1112061 337212 MEXL-1504/U4 U4A13X2054 30011038 MEXL-1504/A4 A4A1222015 351023 MEXL-1504/U4 U4A1322026 337071 MEXL-1504/U4 U4B1642106 30008395 MEXL-1504/A4 A4A1222017 347963 MEXL-1504/S4 S4A10X2047 315713 MEXL-1504/S3 S3A08Z2019 303586 MEXL-1504/U4 U4B1522092 358163 MEXL-1504/A4 A4A11X2004 30018147 MEXL-1504/T4 S4D1132074 347260 MEXL-1504/U4 U4B1422064 30021502 MEXL-1504/U4 U4A1312022 30004266 MEXL-1504/U4 U4A1352036 30001882 MEXL-1504/U4 U4A1372046 337083 MEXL-1504/T4 S4D1142076 341529 MEXL-1504/U4 U4A13Z2057 30005810 MEXL-1504/A4 A4A11Z2010 349167 MEXL-1504/U4 U4A1292007 349175 MEXL-1504/U4 U4B1632105 366015 MEXL-1504/U4 U4B1492081 376523 MEXL-1504/U4 U4A1352037 389696 MEXL-1504/U4 U4A1312021 353532 MEXL-1504/U4 U4B1482077 392326 MEXL-1504/A4 A4A11X2002 333633 MEXL-1504/U4 U4B14Y2082 30018555 MEXL-1504/U4 U4A13X2051 325434 MEXL-1504/A4 A4A11Y2006 350868 MEXL-1504/A4 A4A1252024 356295 MEXL-1504/U4 U4B1532094 30027785 MEXL-1504/U4 U4B1652107 30009792 MEXL-1504/S3 S3A0922023 299545 MEXL-1504/U4 U4A1382049 30007016 MEXL-1504/U4 U4A12Z2014 356808 MEXL-1504/S3 S3A0892009 301747 MEXL-1504/A4 A4A11X2003 324905 MEXL-1504/S3.004 S3A0882007 30024991 MEXL-1504/T4 S4D1132073 339838 MEXL-1504/U4 U4A1362039 393723 MEXL-1504/U4 U4B1462074 356287 MEXL-1504/U4 U4B1522091 30006245 MEXL-1504/U4 U4A1342033 30004737 MEXL-1504/U4 U4A1342034 30001465 MEXL-1504/U4 U4A12X2009 354860 MEXL-1504/U4 U4A1412059 383292 MEXL-1504/U4 U4A1412063 30003291 MEXL-1504/U4 U4A1282004 356881 MEXL-1504/U4 U4A1352038 30004544 MEXL-1504/U4 U4A12Y2013 359834 MEXL-1504/U4 U4B14Z2086 30023668 MEXL-1504/U4 U1A13Z2001 30007654 MEXL-1504/S3 S3A0942027 314575 MEXL-1504/U4 U4A1272001 357343 MEXL-1504/U4 U4A1292006 384206 MEXL-1504/S4 S4A1042023 308445 MEXL-1504/S3 S3A08Z2016 308437 MEXL-1504/A4 A4A11X2001 342766 MEXL-1504/U4 U4B1512089 30006322 MEXL-1504/A4 A4A1212012 352641 MEXL-1504/U4 U4A1342029 314591 MEXL-1504/T4 S4E1192095 340919 MEXL-1504/U4 U4A1362041 30004910 MEXL-1504/U4 U4A12Y2012 356816 MEXL-1504/U4 U4A1382050 30006997 MEXL-1504/A4 A4A1242021 345363 MEXL-1504/S4 S4A1092046 333104 MEXL-1504/A4 A4A1252023 348078 MEXL-1504/U4 U4B15Y2102 30002102 MEXL-1504/U5 U5B15Z2001 30002103 MEXL-1504/T4 S4D1132071 328690 MEXL-1504/U4 U4A13Y2056 30004937 MEXL-1504/S4 S4A1092043 310631 MEXL-1504/U4 U4A1322027 394526 MEXL-1504/U4 U4B1522093 30007522 MEXL-1504/U4 U4A1412061 389344 MEXL-1504/S3 S3A0872005 298422 MEXL-1504/U4 U4A12Z2017 357400 MEXL-1504/A4 A4A1212013 349118 MEXL-1504/U4 U4B1482076 30020797 MEXL-1504/U4 U4B1552098 30012104 MEXL-1504/A4 A4A1222019 352146 MEXL-1504/S4 S4A1052025 324327 MEXL-1504/U4 U4A1292008 356568 MEXL-1504/A4 A4A1222016 340950 MEXL-1504/U4 U4B1432067 30007279 MEXL-1504/U4 U4A1362042 357418 MEXL-1504/S4 S4A1092045 333047 MEXL-1504/U4 U4B1452071 30009112 MEXL-1504/A4 A4A1242022 351429 MEXL-1504/A4 A4A1262025 394677 MEXL-1504/S4 S4A1082036 331306 MEXL-1504/S4 S4C1112060 340539 MEXL-1504/T4 S4D1152081 342436 MEXL-1504/S4 S4A09X2001 317842 MEXL-1504/U4 U4A12Z2019 356063 MEXL-1504/T4.004 S4D1142079 372281 MEXL-1504/U4 U4B1512090 30011831 MEXL-1504/U4 U4A13X2055 372615 MEXL-1504/U4 U4A1362044 30008519 MEXL-1504/A4 A4A11X2005 343723 MEXL-1504/U4 U4B15X2101 30008684 MEXL-1504/S4 S4A1072032 316471 MEXL-1504/U4 U4B1482079 377483 MEXL-1504/U4 U4B1582100 30004842 MEXL-1504/S4 S4A1022013 313254 MEXL-1504/S4 S4A1022014 313262 MEXL-1504/U4 U4B1612103 30029397 MEXL-1504/T4 S4D1132070 337303 MEXL-1504/U4 U4A1382048 30003156 MEXL-1504/U4 U4B1612104 385256 MEXL-1504/T4 S4E1182093 342311 MEXL-1504/U4 U4A13X2052 380285 MEXL-1504/U4 U4A12Z2015 356840 MEXL-1504/U4 U4B1452072 369092 MEXL-1504/U4 U4B1452073 30007850 MEXL-1504/U4 U4B1582099 30006070 MEXL-1504/S4 S4A1022015 326512 MEXL-1504/U4 U4B14Y2084 365309 MEXL-1504/S3 S3A08Y2013 292490 MEXL-1504/S4 S4B10Z2058 336701 MEXL-1504/S3 S3A09X2039 351542 MEXL-1504/S4 S4A1092044 308189 MEXL-1504/A4 A4A1222018 345587 MEXL-1504/A4.007 A4A1222014 392554 MEXL-1504/T4 S4D1172089 345140 MEXL-1504/U4 U4B1432066 30008575 MEXL-1504/U4 U4B1442069 30007942 MEXL-1504/S4 S4A1082041 329656 MEXL-1504/S3 S3A09X2041 311514 MEXL-1504/A4 A4A11Y2008 348169 MEXL-1504/S3 S3A08Y2012 311506 MEXL-1504/S4 S4A1062030 311522 MEXL-1504/S3 S3A0992038 304907 MEXL-1504/U4 U4B1472075 348151 MEXL-1504/S3 S3A09X2040 MEXL-1504/S4 S4A1042022 326355 MEXL-1504/U4 U4B1512087 30009776 MEXL-1504/T4 S4D1162086 344267 MEXL-1504/U4 U4A1342031 351320 MEXL-1504/U4 U4A1342032 30005999 MEXL-1504/U4 U4A1362040 30007243 MEXL-1504/S4 S4B10Y2053 334979 MEXL-1504/S4 S4C1112066 337048 MEXL-1504/U4 U4A12Z2016 394744 MEXL-1504/S3 S3A0972031 299453 MEXL-1504/U4 U4A1282005 30003217 MEXL-1504/U4 U4B1512088 30027396 MEXL-1504/S4 S4A1052026 336677 MEXL-1504/S4 S4A1012011 299271 MEXL-1504/U4 U4B14Z2085 30020944 MEXL-1504/U4 U4A1332028 30002698 MEXL-1504/U4 U4A13X2053 30008346 MEXL-1504/U4 U4B1442068 30008347 MEXL-1504/U4 U4A1412060 30008348 MEXL-1504/U4 U4A1362045 30008837 MEXL-1504/U4 U4B14Y2083 30008842 MEXL-1504/U4 U4B1482078 30010457 MEXL-1504/U4 U4B1422065 350207 MEXL-1504/U4 U4A1342030 362189 MEXL-1504/S4 S4A09Y2003 306985 MEXL-1504/U4 U4B1492080 30002625 MEXL-1504/S3 S3A0992036 307538 MEXL-1504/U4 U4B1542095 391411 MEXL-1504/U4 U4B1542096 380834 MEXL-1504/U4 U4A1412062 366506 MEXL-1504/S4 S4A1012009 308056 MEXL-1504/U4.004 U4A1282002 30027784 MEXL-1504/U4.004 U4A1382047 30036224 MRT-1504/S4 S4A1052027 330217 MEXL-1504/U4.004 U4A12Z2018 MEXL-1504/U4.004 U4A1362043 MEXL-1504/U4.004 U4A12Z2018 MEXL-1504/U4.004 U4A1362043 Model MEXL-1510 MEXL-1510/S2 S2B1642037 MEXL-1510/S2 S2A15Y2019 MEXL-1510/S2/E S2B16Y2055 MEXL-1510/S2 S2B1652041 MEXL-1510/S2 S2C1762072 MEXL-1510/S3 S3A16Z2007 MEXL-1510/S2/E S2C1772077 MEXL-1510/S2 S2A1592013 MEXL-1510/S3 S3B1782012 MEXL-1510/S2 S2A1612025 MEXL-1510/S2/E S2B1692050 MEXL-1510/S3 S3A1692003 MEXL-1510/S2/E S2C1772075 MEXL-1510/S3 S3B17Y2016 MEXL-1510/S2 S2A15Z2023 MEXL-1510/S2 S2A15Y2018 MEXL-1510/S2/E S2C1772074 MEXL-1510/S2 S2C1782081 MEXL-1510/S3 S3B1762010 MEXL-1510/S2 S2C1762071 MEXL-1510/S3 S3B1762009 MEXL-1510/S2 S2C1782082 MEXL-1510/S2 S2B1632035 MEXL-1510/S2/E S2D1812097 MEXL-1510/S2 S2A1582010 MEXL-1510/S2/E S2B16Z2061 MEXL-1510/S2/E S2B1732065 MEXL-1510/S2 S2B1632036 MEXL-1510/S2 S2B1672045 MEXL-1510/S3 S3B17X2015 MEXL-1510/S2 S2B1632030 MEXL-1510/S3 S3A16Z2006 MEXL-1510/S2/E S2B1642040 MEXL-1510/S2 S2A1612024 MEXL-1510/S2 S2C1752070 MEXL-1510/S2/E S2C1772076 MEXL-1510/S2 S2B1692048 MEXL-1510/S2 S2B1692049 MEXL-1510/S2 S2A1572008 MEXL-1510/S2 S2B1622029 MEXL-1510/S2 S2A1582012 MEXL-1510/S3 S3A16Y2004 MEXL-1510/S2/E S2B16X2054 MEXL-1510/S3 S3B1782013 MEXL-1510/S2 S2A15Y2016 MEXL-1510/S2 S2B1642039 MEXL-1510/S2 S2B16Y2058 MEXL-1510/S2 S2B1632031 MEXL-1510/S2/E S2C17Y2093 MEXL-1510/S2 S2C1772078 MEXL-1510/S3 S3B1772011 MEXL-1510/S3 S3A16Z2005 MEXL-1510/S3 S3B1782014 MEXL-1510/S2 S2B16Z2060 MEXL-1510/S2 S2A1562006 MEXL-1510/S2 S2A15Z2021 MEXL-1510/S2/E S2C1772079 MEXL-1510/S2 S2A1552005 MEXL-1510/S2 S2A1612026 MEXL-1510/S2/E S2C17Y2090 MEXL-1510/S2 S2D1822098 MEXL-1510/S2 S2D1832101 MEXL-1510/S3 S3C1812017 MEXL-1510/S3 S3C1832018 Model MEXL-1520 MEXL-1520/S1 S1C1672334 30032698 MEXL-1520/S1 S1C1682336 30035150 MEXL-1520/S1 S1C1722390 30040716 MEXL-1520/S1 S1D17Y2461 30036289 MEXL-1520/S1 S1B1492068 70000226
• Recalling Firm/ Manufacturer: Canon Medical System, USA, INC.; 2441 Michelle Dr; Tustin CA 92780-7047
• For Additional Information Contact: Terry Schultz; 714-730-5000
• Manufacturer 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.
• FDA Determined Cause: 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 sequence 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. The 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. Applicable System/Model: -MEXL-1504/MEXL-1510: Vantage Titan -MEXL-1520: Vantage Elan Corrective Action: Modified 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. Request to Customers: Until 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. Please share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility. Customers 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. If you have any questions, please feel free to contact Regulatory Affairs at (800) 421-1968 or your local service representative at (800) 521-1968.
• Quantity in Commerce: 252
• Distribution: 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. International: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LNH