CLASS II ONGOING Device recall · Reported 22 Apr 2020 · FDA Enforcement Report

Canon Aquilion Prime SP recalled by Canon Medical System, USA

Canon Medical System, USA is recalling Canon Aquilion Prime SP, distributed in 28 states. The recall was initiated on 25 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCanon Aquilion Prime SP, Multislice Helical CT Scanner, Model TSX-303B - Serial numbers 1LB1882092, 1LB1882088, 1LB18X2111, 1LB1882086, 1LB18X2129, 1LB18X2109, 1LB1882087, 1LB1882090, 1LB1892093, and 1OB1892102.

Quantity recalled10 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1724-2020
FDA event ID: 84954
Recalling firm: Canon Medical System, USA, Tustin, CA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Mar 2019
FDA classified: 16 Apr 2020
Reported: 22 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Mar 2019	Recall initiated by company
16 Apr 2020	Classified by FDA	+388 days
22 Apr 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Canon Aquilion Prime SP, Model TSX-303B

Where it was distributed

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.

Alaska Arkansas California Florida Iowa Idaho Illinois Kansas Massachusetts Maryland Michigan Minnesota Missouri Montana North Carolina North Dakota New Hampshire New York Ohio Oklahoma

Questions about this recall

Is Canon Aquilion Prime SP recalled?

Yes. Canon Medical System, USA recalled Canon Aquilion Prime SP on 25 Mar 2019. The recall is Class II and its status is Ongoing. Recall number Z-1724-2020.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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