Recall Z-1240-2025 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare (China) Co., Ltd.
Brivo MR355, NMRI system
| Date | Feb 28, 2025 (initiated Jan 31, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | On January 31, 2025, the firm notified customers through Urgent Medical Device Correction letters. Customers were provided with instructions for continued use of their MR systems. All potential users should be made aware of this safety notification and recommended actions. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 22 |
| Distribution | Domestic US distribution nationwide. International distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123417 | BRIVO MR355, OPTIMA MR360 Ge Hangwei Medical Systems Co., Ltd., Jan 17, 2013 |