CLASS II ONGOING Device recall · Reported 21 Jul 2021 · FDA Enforcement Report

Canon Vantage Titan 3T, Premium Open-Bore MRI System recalled

Canon Medical System, USA is recalling Canon Vantage Titan 3T, Premium Open-Bore MRI System, distributed nationwide in the US. The recall was initiated on 21 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAffected Serial Numbers: A5B1182002, A5B11Y2005, A5D14X2032, A5A1082001, A5C12Y2017, A5D13Y2025, A5C1412028, S7A1642006, A5D13Y2026, A5F1562034, A5B1192004, A5C1222010, A5C1212009, A5C12X2016, A5G1692038, A5G1642036, A5C1232011, A5C1252012, A5D13Z2027, A5D1492030, A5C1262013, A5E1522033, A5G1692039, A5D14X2031, A5B1192003, A5B11Y2006, A5D1312019, A5G1652037, A5D1362021, A5C1292015, A5D13X2024, A5C1422029, A5D1322020, A5B11Z2007, A5C1212008, A5C12Z2018, A5D1372022

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-2046-2021
FDA event ID: 88014
Recalling firm: Canon Medical System, USA, Tustin, CA
Classification: Class II
Status: Ongoing
Recall initiated: 21 May 2021
FDA classified: 9 Jul 2021
Reported: 21 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

21 May 2021	Recall initiated by company
9 Jul 2021	Classified by FDA	+49 days
21 Jul 2021	Published in enforcement report	+12 days

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

Reason for recall

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

Where it was distributed

US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan

Questions about this recall

Is Canon Vantage Titan 3T, Premium Open-Bore MRI System recalled?

Yes. Canon Medical System, USA recalled Canon Vantage Titan 3T, Premium Open-Bore MRI System on 21 May 2021. The recall is Class II and its status is Ongoing. Recall number Z-2046-2021.

Why was it recalled?

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

Which lots are affected?

Affected Serial Numbers: A5B1182002, A5B11Y2005, A5D14X2032, A5A1082001, A5C12Y2017, A5D13Y2025, A5C1412028, S7A1642006, A5D13Y2026, A5F1562034, A5B1192004, A5C1222010, A5C1212009, A5C12X2016, A5G1692038, A5G1642036, A5C1232011, A5C1252012, A5D13Z2027, A5D1492030, A5C1262013, A5E1522033, A5G1692039, A5D14X2031, A5B1192003, A5B11Y2006, A5D1312019, A5G1652037, A5D1362021, A5C1292015, A5D13X2024, A5C1422029, A5D1322020, A5B11Z2007, A5C1212008, A5C12Z2018, A5D1372022

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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