GE Healthcare (China) Co., Ltd. Recall 96311
Description: Brivo MR355, NMRI system
GE Healthcare (China) Co., Ltd. Recall 96311 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1240-2025 |
| Event ID | 96311 |
| Event Description | Brivo MR355, NMRI system |
| Product Type | Devices |
| Distribution | Domestic US distribution nationwide. International distribution worldwide. |
| Quantity | 22 |
| Recall 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. |
| Device Classification | 20250305 |
| Device Code Info | Brivo MR355 (No UDI) System IDs 082427010096 082427020046 082427040126 082427070076 082427070077 082427070170 082427100245 082427120151 082427180030 082427210147 082427210148 082427220025 082427220045 082427230060 082427240060 082427310104 0856270058 0856270059 MRR10200 MRR9920 RU1063MR03 RU8902MR01 |
| Center Classification Date | 20250227 |
| Recall Initiation Date | 20250131 |
| Recalling Firm | GE Healthcare (China) Co., Ltd. |
| Initial Notification | Letter |
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