FDAClass IIApril 22, 2020

Canon Aquilion Prime recall

Canon Aquilion Prime, Model TSX-303A

Why was Canon Aquilion Prime 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Canon Aquilion Prime, Model TSX-303A
Recalling firm
Canon Medical System, USA, INC.
Quantity
10 devices
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.
Recall date
April 22, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls