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.
Reason for recall: 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. Distribution: 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. Quantity: 118 Lot/code info: 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
04987670103360, 04987670104831
Official record: FDA (Device enforcement) ↗
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