# FDA recall Z-1248-2024

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2024-01-29.

## Product

MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550

## 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.

## Distribution

Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.

## Key facts

- **Recall number:** Z-1248-2024
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-29
- **Report date:** 2024-03-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1248-2024

## Citation

> AI Analytics. FDA recall Z-1248-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1248-2024. Source: US FDA. Licensed CC0.

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