FDA Device recall Z-2045-2021
Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces…
- FDA Device
- Class II
- ongoing
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces… by Canon Medical System Usa, citing the MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2045-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-21 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
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
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
Identifiers
| code_info | Affected Serial Numbers: S3C18Y2032, S3C1892029, S3C1912035, S3C2042045, S3A16Z2007, S3B1782012, S3A1692003, S3C1912036…Affected Serial Numbers: S3C18Y2032, S3C1892029, S3C1912035, S3C2042045, S3A16Z2007, S3B1782012, S3A1692003, S3C1912036, S3C2012043, S3C1882028, S3C19Z2042, S3B17Y2016, S3C1842019, S3C1912034, S3C18Z2033, S3C2012044, S3C2082046, S3B1762010, S3B1762009, S3C1872025, S3C1932039, S3C1812017, S3C19Z2041, S3C1832018, S3B17X2015, S3A16Z2006, S3C1852021, S3C18X2030, S3C1932040, S3C1922038, S3A16Y2004, S3B1782013, S3C1842020, S3C1882026, S3C1912037, S3B1772011, S3A16Z2005, S3C1882027, S3B1782014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2045-2021%22
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