Z-1248-2024 Class II Ongoing
FDA device recall Z-1248-2024 was initiated by Canon Medical System, USA, INC. on Jan 29, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 118.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 13, 2024
- Initiation Date
- Jan 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118
Product Description
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
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 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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1248-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026