Recall Z-1243-2025— GE Healthcare (China) Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare (China) Co., Ltd., initiated 2025-01-31. FDA's recall record names no specific 510(k) clearance for this event. Product: SIGNA MR380, NMRI system, Non-US Only. 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..
- Recalling firm
- GE Healthcare (China) Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-31
- Firm location
- Beijing, N/A, China
Product description
SIGNA MR380, NMRI system, Non-US Only
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.