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Recall Observatory FDA recall evidence

Device 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.

Z-2044-2021

May 21, 2021

Class II

Product summary

Firm
Canon Medical System, USA, INC.
Event
Event 88014
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2044-2021

Official wording

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

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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