MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Summary
The FDA issued a Class II for MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 by Canon Medical System, USA, INC.. 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 operatio.
Details
Source
Device Recall
External ID
Z-1248-2024
Action Date
2024-03-13
Status
Ongoing
Category
device
Product Description
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
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
Quantity Affected: 118
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-29
Company
Tustin, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Canon Medical System, USA, INC. has 25 FDA actions in our database, including 25 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Canon Medical System, USA, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Canon Medical System, USA, INC. have FDA actions?
Canon Medical System, USA, INC. has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1248-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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