RecallRadar

FDA Device recall Z-1724-2020

Canon Aquilion Prime SP, Model TSX-303B

On 2020-04-22 the FDA classified a Class II recall of Canon Aquilion Prime SP, Model TSX-303B 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-1724-2020
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 SP, Model TSX-303B

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 SP, Multislice Helical CT Scanner, Model TSX-303B - Serial numbers 1LB1882092, 1LB1882088, 1LB18X2…Canon Aquilion Prime SP, Multislice Helical CT Scanner, Model TSX-303B - Serial numbers 1LB1882092, 1LB1882088, 1LB18X2111, 1LB1882086, 1LB18X2129, 1LB18X2109, 1LB1882087, 1LB1882090, 1LB1892093, and 1OB1892102.

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-1724-2020%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.