# FDA recall Z-1241-2025

> **GE Healthcare (China) Co., Ltd.** · Class II · device recall initiated 2025-01-31.

## Product

Optima MR360, NMRI system

## Reason for recall

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

## Distribution

Domestic US distribution nationwide. International distribution worldwide.

## Key facts

- **Recall number:** Z-1241-2025
- **Recalling firm:** GE Healthcare (China) Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-31
- **Report date:** 2025-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Beijing, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1241-2025

## Citation

> AI Analytics. FDA recall Z-1241-2025. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1241-2025. Source: US FDA. Licensed CC0.

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