Canon Vantage Tiitan 1 — Class II medical device recall Z-2045-2021
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-2045-2021 |
|---|---|
| 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 | S3A1692003, S3A16Y2004, S3A16Z2005, S3A16Z2006, S3A16Z2007, S3B1762009, S3B1762010, S3B1772011, S3B1782012, S3B1782013, S3B1782014, S3B17X2015, S3B17Y2016, S3C1812017, S3C1832018, S3C1842019, S3C1842020, S3C1852021, S3C1872025, S3C1882026, S3C1882027, S3C1882028, S3C1892029, S3C18X2030, S3C18Y2032 and 14 more |
| Model numbers | MRT-1510 |
Product
Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - 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-2045-2021. 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.