Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SIGNA MR380 Recalled by GE Healthcare (China) Co., Ltd. Due to For certain MR systems, a scan can be...

Date: January 31, 2025
Company: GE Healthcare (China) Co., Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare (China) Co., Ltd. directly.

Affected Products

SIGNA MR380, NMRI system, Non-US Only

Quantity: 188

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GE Healthcare (China) Co., Ltd.

GE Healthcare (China) Co., Ltd. has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report