FDA-Device2016-07-13Class II
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore technology, making patient comfort a priority. To offer an enhanced level of performance, we are crossing over to Toshibas new 3T Conform Technology. Vantage Titan 3T features a pat
Toshiba American Medical Systems Inc
Hazard
A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
Sold states
US Nationwide Distribution
Affected count
33 units
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore technology, making patient comfort a priority. To offer an enhanced level of performance, we are crossing over to Toshibas new 3T Conform Technology. Vantage Titan 3T features a patient aperture of 71 cm and Pianissimo noise reduction technology. It comes with a new, fully functional, state-of-the-art interface designed for ease of use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2135-2016Don't want to check this manually?
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