Canon Vantage Galan 3T — Class II medical device recall Z-2047-2021
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-2047-2021 |
|---|---|
| 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 | D5A2062003, D5A2082005, D5A2092007, S5A1662001, S5A1732018, S5A1732019, S5A1742021, S5A17X2033, S5A17Y2035, S5B17X2034, S5B1842043, S5B18X2046, S5C18Y2048, S5C1912050, S5C1972054, S7B1892004, S7B1962013, S7B1992017 |
| Model numbers | MRT-3020 |
Product
Canon Vantage Galan 3T, REF: MRT-3020 - 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-2047-2021. 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.