MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550

Reason: For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.

Code information: UDI-DI: 04987670103360, 04987670104831. Serial Numbers: S2A1962005, S6B2312016, S2B2042009, S6B2262010, S4B2062020, S5B2292037, S2B2052011, S2B20Z2015, S6A20Z2001, SFA2372005, S5B2272031, S8B22X2013, S5B2122013, S8B2272009, S5B2172019, S2A1942004, S2C2252023, S2A18Z2001, S2A18Z2002, S5B22Z2043, S2C2192020, S2A18Z2003, S2B2052010, S5B2352047, S5B2272030, S6B2262011, S5B2182021, S6B2222006, PDA22Y2003, S6B2362019, S5A2062007, S6B2252009, S5A1982001, S2C2142017, POA2292008, S1A1922022, S2B2072012, S2B2072013, S4A1992013, S3A19Z2013, S3A1982009, S1B2042051, S5B2242027, S5A19Z2003, S6B2222005, S6B22Z2014, S5A20Z2009, S5B2142015, S5A20Z2010, S7B22Y2047, S5B2172018, S1B2062057, S5A2092008, S6B2112002, S2C2212022, S2C2272025, S6B2182004, POA2282007, S1B2092067, S2C2132016, S5B2282034, S5B2272029, S8B22X2012, S6B2322018, S5B2292038, S5B2282033, S6B22Z2015, S5B2282032, S1C2152071, SFA22Z2002, S2C2162019, S2B2072014, S2C2162018, S1C2142070, S6B2292013, S5B2132014, S2C21Y2021, POA21X2002, S6B2252007, PDA21Y2001, S1C2262081, S5B22Z2042, S7B2122011, S8B2212007, S6B2322017, S5B2292036, POA2182001, S8B2272010, POA2212003, POA22X2010, POA2272006, POA2262005, S5B2292035, POA2252004, S1C2242080, PDA2312004, S6B2252008, S2C2252024, POA2342011, S6B2272012, POA2292009, S8B2312015, S8B22Y2014, PDA2282002, S8B2292011, SFA2332003, SGA2362032, PDA2342005, S6B2382021, S5B22Z2041, S5B22Y2040, S5B2162017, S1C2342084, S1C2352085, SAB2382012, SGA22Z2011, SGA2372034, SHA2382011

Distribution pattern: Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.