Reported Jun 19, 2024 · Ongoing
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504),…
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- 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)
- Lot codes and dates
- Model/UDI-DI/Serial NumbersMRT-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
- Amount recalled
- 153
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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