Canon Medical System, USA, INC.: Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: 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. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

Recall number

Z-2044-2021

Recalling firm

Canon Medical System, USA, INC.

Product

Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: 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. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

Status

Open, Classified

Initiated

2021-05-21

Posted

not on file

Terminated

not on file

Reason

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

Root cause

Under Investigation by firm

Action

On May 25,2021, Canon issued a "URGENT: MEDICAL DEVICE CORRECTION" via USPS First Class Return Receipt. On June 24,2021, Canon sent an updated recall communication via USPS First Class Return Receipt to affected consignees to provide additional information. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Your local Canon Service person will schedule time to replace the applicable part with a part that meets specifications. At the same time an inspection of the gantry will be performed. 2. Until such time that the modification work is provided by your service representative if any smoke or abnormal odor are observed, immediately stop using the system and contact your service representative. 3. Please share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility. 4. Please complete the attached form that is attached and return by either fax, to the toll-free number shown at the top of the form, or by via email to RAffairs@us.medical.canon. This form is a record required by FDA for verification that this notification has been received. 5. If you have any questions, please feel free to contact Terry Schultz Regulatory Affairs Manager at (800) 421-1968 or your local Canon Medical Systems service representative at (800) 521-1968.

Quantity

not on file

Distribution

US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Lot, serial or model codes

Affected serial numbers: U4A12Z2020, S4D1132069, S4A1032017, U4B1492081, U4B1582100, S4A1072035, A4A1222019, S4D1172090, U4A1312024, S4A1072034, S4A1082040, A4A11Z2011, U4A1282003, U4B1442070, U4A1352035, U4B1552097, U4A12X2010, S4C1112065, S4C1112064, S3A0922024, S4E1192094, A4A11Z2009, S3A0972032, S4A09Y2002, S4A09Z2006, U4A1382047, S4A1062031, S3A0972030, U4A12X2011, S4C1112061, U4A13X2054, A4A1222015, U4B1642106, A4A1222017, S4A10X2047, S4A09Z2007, U4B1522092, A4A11X2004, S4D1132074, U4A1312023, S4A1052025, S3A0982035, S3A08Y2014, U4A1312022, S4B10Y2051, U4A1352036, U4A1372046, S4D1142076, U4A1292007, U4B1632105, S4B10Y2052, U4A1352037, U4A12Z2018, U4A1312021, U4B1482077, A4A11X2002, U4B14Y2082, U4A13X2051, S4B10Y2050, A4A1252024, U4B1532094, U4B1652107, S3A0922023, S4B10Z2059, S4A09Z2008, U4A1382049, S4D1142078, L3A08Z2002, U4A12Z2014, S3A0822001, A4A11Z2010, S3A0852004, S3A0892009, A4A11X2003, S3A0882007, S4D1132073, U4A1362039, U4B1462074, U4B1522091, U4A1342033, U4A1342034, U4A12X2009, U4A1412059, U4A1412063, U4A1282004, U4A1352038, U4A12Y2013, U4B14Z2086, S4A1022016, S3A0942027, S4D1162084, U4A1292006, S4A1042023, U4B1512089, A4A11X2001, U4A1342029, S4E1192095, U4A1362041, U4A12Y2012, S4A1032018, S3A0952029, U4A1382050, A4A1242021, S4A1092046, A4A1252023, S3A0982033, U4B15Y2102, S4A09Y2004, S4D1132071, S4D1142075, U4A13Y2056, S4A10X2048, S4A1092043, U4B1522093, A4A1232020, A4A11Y2007, S4D1162087, S4A1012010, U4A1412061, S3A1062029, S4D1172088, S3A0872005, A4A1212013, U4B1482076, S4C1112063, U4B1552098, S4D1152080, S4A1042021, S4B10Z2057, U4A1292008, A4A1222016, U4B1432067, U4B1492080, U4A1362042, S4A1092045, S4A1062028, U4B1452071, A4A1242022, A4A1262025, S4A1082036, S4C1112060, S4D1152081, U4A12Z2019, U4B1512090, S4A1042024, U4A13X2055, S4D1132072, A4A11X2005, U4B15X2101, U4B1482079, S4A1072032, U4A12Z2017, S4A1022013, U4B1612103, S4D1132070, S3A0872006, U4A1322025, U4A1382048, S3A0892008, U4B1612104, S4E1182093, U4A13X2052, U4B1542095, S4A1042020, S4A1082037, U4A12Z2015, S3A0922025, S3A0982034, U4B1452072, S4A09Z2005, U4B1452073, U4B1582099, S4A1022015, U4B14Y2084, S3A08X2010, S4D1162085, S3A08Y2013, S4A1092044, S4B10Y2055, A4A1222018, A4A1222014, S4D1172089, U4B1432066, U4B1442069, U4A13Z2057, L3A08Z2001, S3A09X2041, A4A11Y2008, S4A1062030, S3A08Y2012, U4B1472075, S3A0992038, S3A0952028, S3A09X2040, U4A1362043, S4A1042022, U4B1512087, S4D1162086, U4A1342031, U4A1342032, U4A1362040, S4B10Y2053, S4E1182092, S4C1112066, S4A1082042, U4A12Z2016, S4A1012009, S4A1082038, S3A0972031, S4B10Z2056, U4A1282005, U4B1512088, S4A1052026, S4A1012011, U4B14Z2085, U4A1412060, U4A1332028, U4A13X2053, U4B1442068, U4A1362045, U4B14Y2083, U4B1482078, U4B1422065, S3A0932026, U4A1362044, S4A1082039, U4B1542096, U4A1412062, S4A1012012, U4A1282002, U4A1342030, S4A09Y2003

510(k) numbers

["K122613"]

PMA numbers

not on file

Product code

LNH

Firm FEI

2020563

Firm city

Tustin

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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