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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-1242-2025
Recall Event ID 96311
510(K)NumberK143251 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductSIGNA MR355, SIGNA MR360, NMRI system
Code Information 1. SIGNA MR355 A. UDI-DI 00840682144407 System IDs 082427010189 082427010193 082427010195 082427010200 082427010202 082427010205 082427010207 082427010208 082427010209 082427010210 082427020099 082427020120 082427020123 082427020127 082427030181 082427030194 082427030199 082427030205 082427030210 082427030213 082427030217 082427030221 082427030228 082427040273 082427040294 082427040303 082427040307 082427040316 082427040318 082427040323 082427060097 082427070236 082427070240 082427070244 082427070247 082427070255 082427070257 082427070279 082427070285 082427070299 082427070309 082427070312 082427070313 082427070316 082427070327 082427070330 082427070335 082427070339 082427070343 082427070344 082427070348 082427080113 082427080116 082427080118 082427080133 082427080135 082427080137 082427090359 082427090474 082427100436 082427100460 082427100461 082427100466 082427100481 082427100500 082427100506 082427110098 082427110106 082427110125 082427110126 082427110147 082427110153 082427120294 082427120297 082427120306 082427120315 082427120332 082427120336 082427120339 082427120348 082427120362 082427120367 082427120374 082427130130 082427140315 082427140332 082427160293 082427160303 082427160311 082427160312 082427160316 082427160327 082427160333 082427160341 082427160351 082427160352 082427160359 082427160364 082427160366 082427160367 082427160369 082427160374 082427160394 082427160397 082427160406 082427160416 082427160419 082427160421 082427170028 082427170032 082427180074 082427190152 082427190159 082427190179 082427190197 082427190198 082427200165 082427200174 082427200187 082427200192 082427200194 082427200198 082427200212 082427200231 082427210234 082427210239 082427210253 082427210259 082427220100 082427220138 082427230173 082427230175 082427230182 082427230187 082427230205 082427230237 082427230238 082427230242 082427240099 082427240100 082427240101 082427240102 082427240103 082427240104 082427240111 082427240113 082427250095 082427250101 082427250116 082427260012 082427270079 082427270085 082427270089 082427290048 082427290061 082427290069 082427290071 082427290073 082427310141 082427310148 082427310149 082427310153 082427310154 082427310160 082427310181 B. No UDI-DI System IDs 082427010215 082427010216 082427010217 082427010218 082427020134 082427030206 082427030209 082427030215 082427060123 082427070248 082427070346 082427070359 082427090460 082427100425 082427100448 082427110089 082427120342 082427130201 082427160368 082427160425 082427180094 082427190145 082427190163 082427190191 082427200218 082427200237 082427210205 082427210265 082427210267 082427230265 082427250100 082427290039 (Updated 2/19/26 - addl systems 82427210271 82427190192 82427200197) 2. SIGNA MR360 A. UDI-DI 00195278361257 System ID 082427140184 B. UDI-DI 00840682144445 System IDs 082427010184 082427010192 082427010201 082427030202 082427060121 082427070254 082427070274 082427100376 082427100377 082427100383 082427100437 082427100501 082427120275 082427120281 082427120282 082427120293 082427120316 082427120361 082427130128 082427130131 082427130132 082427140245 082427150115 082427160298 082427160308 082427160328 082427170036 082427190175 082427190201 082427200180 082427200188 082427220115 082427230161 082427230167 082427240090 082427250125 082427300035 082427310164 C. No UDI-DI System IDs 082427040351 082427120270 082427150137 082427210242 082427230268 (Updated 2/19/26 - addl systems 82427150142 82427090508)
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 Commerce241
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.
510(K) Database510(K)s with Product Code = LNH
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