FDAClass IIApril 22, 2020

Canon Aquilion One Vision recall

Canon Aquilion One Vision, Model TSX-301C

Why was Canon Aquilion One Vision 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 ONE, Whole-Body X-Ray CT Scanner, Model TSX-301C - Serial number 3DC18Y2118.

Product
Canon Aquilion One Vision, Model TSX-301C
Recalling firm
Canon Medical System, USA, INC.
Quantity
1 device
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)
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