FDA Device recall Z-1243-2025
SIGNA MR380, NMRI system, Non-US Only
- FDA Device
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of SIGNA MR380, NMRI system, Non-US Only by Ge Healthcare China, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1243-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-31 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Healthcare China |
| Distribution | US |
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.
Identifiers
| code_info | SIGNA MR380 UDI-DI 00195278361257 System IDs 082427020110 082427020116 082427040288 082427040293 082427040296 0824270…SIGNA MR380 UDI-DI 00195278361257 System IDs 082427020110 082427020116 082427040288 082427040293 082427040296 082427040309 082427070258 082427070264 082427070267 082427070268 082427070272 082427070275 082427070284 082427070286 082427070287 082427070288 082427070289 082427070292 082427070293 082427070294 082427070295 082427070303 082427070304 082427070305 082427070306 082427070307 082427070310 082427070311 082427070317 082427070320 082427070337 082427090417 082427090428 082427090431 082427090439 082427090462 082427090468 082427100424 082427100427 082427100428 082427100438 082427100443 082427100452 082427100453 082427100465 082427100467 082427100468 082427100470 082427100472 082427100488 082427100498 082427110124 082427110127 082427110131 082427110134 082427110136 082427110137 082427110139 082427110158 082427120299 082427120310 082427120312 082427120317 082427120318 082427120329 082427120347 082427130133 082427130135 082427130136 082427130137 082427130138 082427130142 082427130149 0824 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1243-2025%22
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