Canon Medical System, USA, INC.: MRI Systems Recalled for Incorrect Safety Data and Gradient Values

What You Should Do

1. Identify if your facility is using an affected MRI system by checking the model and serial numbers. Affected models include Vantage Orian and Vantage Fortian (MRT-1550), Vantage Elan (MRT-2020), and Vantage Titan (MRT-1504).
2. For the Vantage Orian and Vantage Fortian (MRT-1550), check for serial numbers such as S2A1962005, S6B2312016, S5B2292037, S2B2052011, and others listed in the recall notice (UDI-DI: 04987670103360, 04987670104831).
3. For the Vantage Elan (MRT-2020), identify the single affected unit with serial number S1F2052753 (UDI-DI: 04987670101632).
4. For the Vantage Titan (MRT-1504), check for 40 serial numbers including U4B15Y2102, U5B15Z2001, U4B1492080, and U4B1612104 (UDI-DI: 04987670102400).
5. If you are a patient scheduled for an MRI and have an implanted medical device, discuss the safety parameters of your specific device with your healthcare provider before the scan.
6. Healthcare facilities should contact Canon Medical System, USA, INC. at 2441 Michelle Dr, Tustin, California, or call their support line to receive the corrected safety manual and software information.
7. Contact your healthcare provider or the manufacturer for further instructions regarding system updates and safety protocols.
8. For more information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products