Z-2046-2021Class II

Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 -

Name: Z-2046-2021 Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 -
Creator: Canon Medical System, USA, INC.
Published: 2021-05-21
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2021-05-21 / Open, Classified

FDA source

Canon Medical System, USA, INC. began a recall of Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional... on 2021-05-21. FDA classified it as Class II and gives the reason as "The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2046-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-21
Posted: 2021-07-09
Recalling firm: Canon Medical Systems USA, Inc.
Product: 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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
FDA root cause: Under Investigation by firm
Action: On May 25,2021, Canon issued a "URGENT: MEDICAL DEVICE CORRECTION" via USPS First Class Return Receipt. On June 24,2021, Canon sent an updated recall communication via USPS First Class Return Receipt to affected consignees to provide additional information. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Your local Canon Service person will schedule time to replace the applicable part with a part that meets specifications. At the same time an inspection of the gantry will be performed. 2. Until such time that the modification work is provided by your service representative if any smoke or abnormal odor are observed, immediately stop using the system and contact your service representative. 3. Please share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility. 4. Please complete the attached form that is attached and return by either fax, to the toll-free number shown at the top of the form, or by via email to [email protected]. This form is a record required by FDA for verification that this notification has been received. 5. If you have any questions, please feel free to contact Terry Schultz Regulatory Affairs Manager at (800) 421-1968 or your local Canon Medical Systems service representative at (800) 521-1968.
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2046-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2044-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-09
Z-2045-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-09
Z-2046-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-09
Z-2047-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-09

Product code LNH

K172878Class IIVantage Titan 3T, MRT-3010/A7, M-Power GXToshiba Medical Systems Corporation, Japan / cleared 2017-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)