Brivo MR355, NMRI system
Reported: March 5, 2025 Initiated: January 31, 2025 #Z-1240-2025
Product Description
Brivo MR355, 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.
Details
- Recalling Firm
- GE Healthcare (China) Co., Ltd.
- Units Affected
- 22
- Distribution
- Domestic US distribution nationwide. International distribution worldwide.
- Location
- Beijing, N/A
Frequently Asked Questions
What product was recalled? ▼
Brivo MR355, NMRI system. Recalled by GE Healthcare (China) Co., Ltd.. Units affected: 22.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2025. Severity: Moderate. Recall number: Z-1240-2025.
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