FDA Medical devices recall ·
SIGNA MR380, NMRI system, Non-US Only recall
- Recall number
- Z-1243-2025
- Date
- (initiated January 31, 2025)
- Company / brand
- GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area, Beijing, N/A, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 188
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SIGNA MR380, NMRI system, Non-US Only
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 082427130154 082427130160 082427130161 082427130162 082427130163 082427130165 082427130166 082427130167 082427130168 082427130169 082427130171 082427130172 082427130178 082427130179 082427140219 082427140220 082427140221 082427140228 082427140230 082427140233 082427140236 082427140238 082427140239 082427140243 082427140244 082427140247 082427140253 082427140254 082427140255 082427140256 082427140260 082427140261 082427140262 082427140263 082427140264 082427140266 082427140269 082427140270 082427140271
Distribution
Domestic US distribution nationwide. International distribution worldwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1243-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.