Toshiba American Medical Systems Inc recalls Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation a…

Recall date

October 25, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0622-2017

FDA classification

Class II

Brand / firm

Toshiba American Medical Systems Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.