Canon Vantage Titan 3T — Class II medical device recall Z-2046-2021
Ongoing recall by Canon Medical System, USA, INC., reported 2021-07-21, distributed nationwide. The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could res
| Recall number | Z-2046-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2021-05-21 |
| Classified | 2021-07-09 |
| Reported by FDA | 2021-07-21 |
| Distributed | Nationwide (US) |
| Serial numbers | A5A1082001, A5B1182002, A5B1192003, A5B1192004, A5B11Y2005, A5B11Y2006, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5C1412028, A5C1422029, A5D1312019, A5D1322020, A5D1362021, A5D1372022, A5D13X2024, A5D13Y2025 and 12 more |
| Model numbers | MRT-3010 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2046-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.