MRI system: Vantage Orian recall
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Why was MRI system: Vantage Orian recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 118
- 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.
- Recall date
- March 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)