MRI systems: Vantage Orian MRT-1550 — Class II medical device recall Z-2041-2024
Ongoing recall by Canon Medical System, USA, INC., reported 2024-06-19, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secur
| Recall number | Z-2041-2024 |
|---|---|
| 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 | 2024-05-10 |
| Classified | 2024-06-09 |
| Reported by FDA | 2024-06-19 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, VT, WI, WV, WY |
| Quantity | 153 |
| UPC / GTIN / UDI-DI | 04987670101632, 04987670101649, 04987670102400, 04987670102615, 04987670103360 |
| Serial numbers | MRT-1550 |
Product
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
Reason for recall
The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and 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-2041-2024. 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.