RecallRadar

FDA Device recall Z-1722-2020

Canon Aquilion One Vision, Model TSX-301C

On 2020-04-22 the FDA classified a Class II recall of Canon Aquilion One Vision, Model TSX-301C 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-1722-2020
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 One Vision, Model TSX-301C

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_infoCanon Aquilion ONE, Whole-Body X-Ray CT Scanner, Model TSX-301C - Serial number 3DC18Y2118.

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-1722-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.