RecallRadar

FDA Device recall Z-1723-2020

Canon Aquilion Prime, Model TSX-303A

On 2020-04-22 the FDA classified a Class II recall of Canon Aquilion Prime, Model TSX-303A by Canon Medical System Usa, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1723-2020
ClassificationClass II
Statusongoing
Initiated2019-03-25
Published2020-04-22
Last updated2026-09-13 11:55 UTC
CompanyCanon Medical System Usa
DistributionAK, 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, WV

Product

Canon Aquilion Prime, Model TSX-303A

Reason

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.

Identifiers

code_info
Canon Aquilion PRIME, TSX-303A - Serial numbers 1CB1892050, FLC1882279, FLC1892282, FLC1882278, FLC18Y2301, FLC1892288,…Canon Aquilion PRIME, TSX-303A - Serial numbers 1CB1892050, FLC1882279, FLC1892282, FLC1882278, FLC18Y2301, FLC1892288, FOC1892284, FOC1872277, FOC18X2289, and FOC18Y2296.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1723-2020%22

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