Vantage Titan — Class II medical device recall Z-1250-2024
Ongoing recall by Canon Medical System, USA, INC., reported 2024-03-13, distributed nationwide. For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed
| Recall number | Z-1250-2024 |
|---|---|
| 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 | 2024-01-29 |
| Classified | 2024-03-04 |
| Reported by FDA | 2024-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 40 |
| UPC / GTIN / UDI-DI | 04987670102400 |
| Serial numbers | U4B1422065, U4B1432066, U4B1432067, U4B1442068, U4B1442069, U4B1442070, U4B1452071, U4B1452072, U4B1452073, U4B1462074, U4B1472075, U4B1482076, U4B1482077, U4B1482078, U4B1482079, U4B1492080, U4B1492081, U4B14Y2082, U4B14Y2083, U4B14Y2084, U4B14Z2085, U4B14Z2086, U4B1512087, U4B1512088, U4B1512089 and 15 more |
| Model numbers | MRT-1504 |
Product
Vantage Titan, Model: MRT-1504
Reason for recall
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
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-1250-2024. 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.