SIGNA MR355, SIGNA MR360, NMRI system
FDA device recall Z-1242-2025 · posted 2025-02-28 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare (China) Co., Ltd.
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LNH
- Quantity affected
- 241
- Distribution
- Domestic US distribution nationwide. International distribution worldwide.
- Date initiated
- 2025-01-31
- Date posted
- 2025-02-28
- Location
- Beijing, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNA Creator, SIGNA Explorer (K143251) | Ge Healthcare (Ge Medical Systems, LLC) | 2015-02-04 |