SIGNA MR380 — Class II medical device recall Z-1243-2025
Ongoing recall by GE Healthcare (China) Co., Ltd., reported 2025-03-05, distributed nationwide. For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" i
| Recall number | Z-1243-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare (China) Co., Ltd., Beijing, N/A, China |
| Recall initiated | 2025-01-31 |
| Classified | 2025-02-27 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 188 |
| UPC / GTIN / UDI-DI | 00082427040296, 00082427070286, 00082427070293, 00082427090468, 00082427100488, 00082427120318, 00082427130133, 00082427130171, 00082427140255, 00082427140262, 00082427140286, 00082427140293, 00082427140316, 00082427210231, 00082427220131, 00082427230239, 00195278361257 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1243-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.