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.
- Hazard
- sar-limit-exceeded
- excessive-tissue-heating
Distribution
Distributed nationwide across the United States.
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