FDA-Device2020-12-16Class II
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
Canon Medical System, USA, INC.
Hazard
A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.
Sold states
US Nationwide distribution. OUS: Unknown
Affected count
60 units
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0549-2021Don't want to check this manually?
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