Home / Recalls / Medical Devices
Canon Medical System, USA, INC. recalls Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modalit
Recalled July 21, 2021 · FDA recall Z-2046-2021 · Canon Medical System, USA
Hazard
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. · FDA Class II
Sold at
US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Description
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
Product
Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
Manufacturer(s)
Canon Medical System, USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →