FDA recall Z-1722-2020

Product

Canon Aquilion One Vision, Model TSX-301C

Reason for recall

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2019-03-25

Report date

2020-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1722-2020