GE SIGNA MR380 NMRI System SAR Limit Exceeded During Scan Resumption
GE SIGNA MR380 NMRI systems may allow scans to resume when the 6-minute average SAR (tissue heating rate) exceeds safe limits, potentially causing excessive tissue heating especially in patients with implants or conductive contact.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a risk-of-harm medical device (potential excessive tissue heating from radiofrequency energy absorption) where no injuries have been reported. The hazard specifically affects patients with implants or conductive contact, and the device's safety mechanism (SAR Display limit) may be bypassed during scan resumption.
Plain-English summary
Certain SIGNA MR380 NMRI (Magnetic Resonance Imaging) systems manufactured by GE Healthcare (China) Co., Ltd. are subject to this recall. A total of 188 systems have been identified with this issue.
The issue occurs when a scan is resumed following a Power Monitor trip. Under these conditions, the system's user interface may incorrectly enable the scan to proceed when the 6-minute average SAR (Specific Absorption Rate)—a measure of tissue heating from radiofrequency energy—exceeds the safety limit shown on the SAR Display. If a scan is resumed in this state, it can result in excessive tissue heating.
Excessive tissue heating poses a particular risk if the patient is in contact with conductive material or has an implant. Implants and conductive contact can concentrate or increase radiofrequency energy absorption, raising the risk of injury.
The recalled product
- Product
- SIGNA MR380, NMRI system, Non-US Only
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Affected units
- 188
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by GE Healthcare (China) Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · GE Healthcare (China) Co., Ltd.
See all →- HighMRI System May Resume Scanning Above Safe Thermal Limits
FDA (Devices) · 2025-03-05
- HighMRI Systems Allow Unsafe Scan Resumption Exceeding SAR Safety Limits
FDA (Devices) · 2025-03-05
- HighGE Healthcare MRI system recalled for RF energy safety control failure
FDA (Devices) · 2025-03-05
- HighMRI Systems May Resume Scans When SAR Exceeds Safe Limits
FDA (Devices) · 2025-03-05
- ModerateGE Healthcare Revolution Frontier CT systems may produce rotated images during scans
FDA (Devices) · 2024-12-11
Same hazard · sar limit exceeded
See all →- HighSIGNA UHP MRI System Software Versions May Cause Implant Overheating
FDA (Devices) · 2024-08-14
- HighDiscovery MR450 MRI System Can Overheat Implants Under Specific Conditions
FDA (Devices) · 2024-08-14