Canon Medical System, USA, INC. recalls Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1

Recall date

March 25, 2019

Source

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

Recall number

Z-1726-2020

FDA classification

Class II

Brand / firm

Canon Medical System, USA, INC.

Sold / distributed

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.

Why it was recalled

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.

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

What was recalled

Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1