FDA-Device2016-11-30Class II
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
Toshiba American Medical Systems Inc
Hazard
Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.
Sold states
Nationwide Distribution
Affected count
291 units
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0622-2017Don't want to check this manually?
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