FDAFDA · Alimentos y medicamentos·N.º oficial Z-2041-2024
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)
Publicado el 19 de junio de 2024 · Inicio del retiro: 10 de mayo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Canon Medical System, USA, INC.
- Distribuidor
- 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
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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