FDA-Device2013-11-20Class II
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Toshiba American Medical Systems Inc
Hazard
Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor.
Sold states
USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.
Affected count
18 units
Manufactured in
2441 Michelle Dr, P.O. Box 2068, Tustin, CA, United States
Products
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0201-2014Don't want to check this manually?
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