Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Canon Aquilion Prime SP Recalled by Canon Medical System, USA, INC. Due to Scanning may be interrupted due to an error...

Date: March 25, 2019
Company: Canon Medical System, USA, INC.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Canon Medical System, USA, INC. directly.

Affected Products

Canon Aquilion Prime SP, Model TSX-303B

Quantity: 10 devices

Why Was This 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.

Where Was This Sold?

This product was distributed to 28 states: AK, AR, CA, FL, ID, IL, IA, KS, MD, MA, MI, MN, MO, MT, NH, NY, NC, ND, OH, OK, OR, PA, TN, TX, VT, WA, WV, WI

Affected (28 states)Not affected

About Canon Medical System, USA, INC.

Canon Medical System, USA, INC. has 49 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report