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U.S. Department of Health and Human Services

Class 2 Device Recall SIGNA

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 Class 2 Device Recall SIGNAsee related information
Date Initiated by FirmJanuary 31, 2025
Date PostedFebruary 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1243-2025
Recall Event ID 96311
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductSIGNA MR380, NMRI system, Non-US Only
Code Information 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 082427140272 082427140276 082427140277 082427140280 082427140281 082427140282 082427140284 082427140286 082427140290 082427140291 082427140292 082427140293 082427140298 082427140302 082427140304 082427140306 082427140312 082427140316 082427150122 082427150123 082427150125 082427150126 082427150133 082427160334 082427160342 082427160371 082427180066 082427180072 082427180073 082427180075 082427180079 082427190189 082427210231 082427210235 082427210243 082427210252 082427220099 082427220101 082427220108 082427220120 082427220131 082427230202 082427230204 082427230207 082427230211 082427230218 082427230221 082427230224 082427230225 082427230229 082427230235 082427230239 082427230243 082427230244 082427270083 082427290054 082427290058 082427310159 082427310166 082427310171 B. No UDI-DI System IDs 082427020125 082427040334 082427090500 082427120298 082427130182 082427130183 082427130185 082427140237 082427140311 082427140313 082427180080 082427210254 082427230209 082427270080 082427270084 082427290062 (Updated 2/19/26 - addl systems 82427150143 82427210255)
Recalling Firm/
Manufacturer		 GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China
For Additional Information ContactGE HealthCare Service
800-4371171
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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.
Quantity in Commerce188
DistributionDomestic US distribution nationwide. International distribution worldwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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