FDA-Device2013-04-17Class II

MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.

Toshiba American Medical Systems Inc
Hazard

It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD Moni

Sold states
USA Nationwide Distribution including the states of : IL, NH, MA, MI, MO, PR, NV, NM, MN, ID, NY, OH, NC, AZ, MS, LA, OR, PA, CA, and CT.
Affected count
27 units
Manufactured in
2441 Michelle Dr, P.O. Box 2068, Tustin, CA, United States
Products
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2013

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