FDA-Device2020-04-22Class II
Canon Aquilion Prime SP, Model TSX-303B
Canon Medical System, USA, INC.
Hazard
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
Sold states
Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV. There was government and military distribution but no foreign distribution.
Affected count
10 devices
Manufactured in
2441 Michelle Dr, Tustin, CA, United States
Products
Canon Aquilion Prime SP, Model TSX-303B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1724-2020Don't want to check this manually?
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