Toshiba Vantage Tiitan 1 — Class II medical device recall Z-2044-2021
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-2044-2021 |
|---|---|
| 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 | A4A11X2001, A4A11X2002, A4A11X2003, A4A11X2004, A4A11X2005, A4A11Y2007, A4A11Y2008, A4A11Z2009, A4A11Z2010, A4A11Z2011, A4A1212013, A4A1222014, A4A1222015, A4A1222016, A4A1222017, A4A1222018, A4A1222019, A4A1232020, A4A1242021, A4A1242022, A4A1252023, A4A1252024, A4A1262025, L3A08Z2001, L3A08Z2002 and 207 more |
| Model numbers | MRT-1504 |
Product
Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - 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-2044-2021. 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.