Recall archive / FDA device enforcement
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504... — FDA record Z-2041-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 10, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
- Reason
- The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.
- Classification
- Class II
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 153
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2041-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model/UDI-DI/Serial Numbers: MRT-1550 (MEXL-1550)/04987670103360/POA21X2002, S5A1982001, S5B22Z2041, S5B2172018, S2C2252024, S5A20Z2009, S2C21Y2021, S2B2052010, S5B2272031, POA2262005, S5B2292036, S5B2272029, S5B2282034, S5B22Y2040, S5B2292035, S6B2252008, S5A20Z2010, POA2252004, POA2182001, S1C2152071, S5B2352047, S2C2252023, S5B2122013, S6B2262010, S2C2192020, S6B2292013, S5B2132014, S6B2322018, S5B2292038, S6B2312016, S2B2052011, S2C2162018, S4A1992013, S3A19Z2013, S3A1982009, S5B2182021, S6B2322017, S5A2092008, S6B2362019, S5B22Z2042, S6B2222005, S2B2042009, S2B20Z2015, S5B2162017, S6B2262011, S5B2272030, S6B22Z2014, S5B2282033, S8B2272009, S5A2062007, S2B2072012, S2B2072013, S6B2222006, S6B2272012, S2B2072014, S6A20Z2001, POA2272006, S5A19Z2003, S1C2142070, POA2212003, S2C2142017, S5B2362048, S2A1962005, S6B2182004, S5B2292037, S6B2252007, S5B2282032, S5B2142015, S5B2382050, S2A18Z2003, S6B2112002, S6B2382021, S1B2042051, S8B2212007, S1B2062057, S1A1922022, S2A18Z2001, S1B2092067, S1C2242080, S5B2172019, S6B2252009, S6B2372020, S2A18Z2002, S2A1942004, S2C2212022, S2C2272025, S6B2392022, S2C2162019, S2C2132016, S4B2062020, S1C2262081, PDA21Y2001, S6B22Z2015, S5B22Z2043, S5B2242027, MRT-2020 (MEXL-1520)/04987670101632/S1F18X2580, S1B1492068, S1D17Y2461, S1F2052753, S1C1722390, S1C1682336, S1E1842517, S1E1842527, S1C1672334, MRT-1504 (MEXL-1504)/04987670102400/U5B15Z2001, MRT-3010 (MEXL-3010)/04987670101649/A5D14X2032, A5C12Y2017, A5D13Y2025, A5C1412028, S7A1642006, A5D13Y2026, A5C1212009, A5C12X2016, A5G1692038, A5G1642036, A5F1562034, A5B11Y2005, A5C1262013, A5E1522033, A5G1692039, A5D14X2031, A5B1192003, A5B11Y2006, A5D1312019, A5D1362021, A5C1252012, A5C1292015, A5D13X2024, A5C1422029, A5B11Z2007, A5C1212008, MRT-3020 (MEXL-3020)/04987670102615/D5A2082005, D5A2092007, D5B2152013, S5B17X2034, D7B2182017, 5DB2152002, S5B18X2046, S5A17X2033, D5A2062003, S5A1742021, D5B2212019, D5B2192016, S5A1662001, S5C18Y2048, S5A1732019, S5A1732018, S5A17Y2035, S7B1892004, S5B1842043, D7B2152015, S5C1972054, 5DB2172003 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ, IL, OK, CA, FL, GA, OR, IN, NJ, CO, MT, KS, MO, WY, VA, VT, LA, NH, WV, TN, PR
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Maryland
- Michigan
- Minnesota
- Missouri
- Montana
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Virginia
- Vermont
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 19, 2024
- Recall initiation date
- May 10, 2024
- Center classification date
- Jun 9, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.