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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-1239-2025
Recall Event ID 96311
510(K)NumberK143251 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductSIGNA Creator, SIGNA Explorer, NMRI systems
Code Information 1. Creator A. UDI-DI 00195278577221, System ID MR00160 MR00171 MR00189 THMR54503051 (Update 12/29/25 - New System ID MRR10626) (Update 1/28/26 - New System IDs MRR10269 850270138) (Update 2/19/26 - Addl System IDs MR00299¿ PHMRI24836517 12440397 13131449¿ PC0084) B. UDI-DI 00195278577238, System ID 083027026539324 5973MR0087 5973MR0091 5973MR0095 5973MR0096 5973MR0097 5973MR0100 5973MR0103 5973MR0104 5973MR0106 5973MR0107 5973MR0109 9830MR0112 9830MR0113 9830MR0114 9830MR0117 A199750201 IDMRI24467771 MR00082 MR00111 MR00120 MR00138 MR00140 MR00143 MR00152 MR00157 MR00174 MR00179 MR00180 MR00187 MR00191 MR00192 MR00195 MR00210 MR00229 MR00231 MR00236 MR00249 MR00251 MR00258 MR00263 MR00282 MRR1170 MRR1182 MRR2198 MRR2508 MRR2860 MRR2916 MRR2938 MRR3171 MRR3873A MRR3954 MRR4356 MRR4501 MRR4726 MRR493 MRR5138 MRR5332 MRR5494 MRR5684 MRR569A MRR6219 MRR673 MRR7117 MRR9626 MRYR2151 VNMRI24476142 VNMRI24513835 (Updated 12/29/25 - Additional System IDs MRR3679 , MR00322) (Updated 2/19/26 - Additional System IDs 83027280426725 83027280425025 MR00219 VNMRI24845558 THMRI25011164¿) C. UDI-DI 00840682113762, System ID 6529149 7361387 07143820 082427030212 082427040272 082427040285 082427060095 082427060119 082427070318 082427080107 082427080129 082427090384 082427090403 082427090419 082427090433 082427090434 082427090436 082427090448 082427100397 082427100418 082427110140 082427120326 082427120330 082427130173 082427160292 082427160307 082427160310 082427160318 082427160319 082427160343 082427160375 082427200201 082427200216 082427220123 082427220126 082427230245 082427230253 082427250094 082427250096 082427250122 082427290064 082427310174 0828270077 0850270635 0850270645 0850270695 0850270772 1553MR0020 1557MR0052 1573MR0064 5973MR0073 7982MR0048 A5421025 A5816111 HU1729MR01 MR00017 MR00018 MR00042 MR51028441 MRR1577 MRR192 MRRD1008 MRRD1027 MRRD1205 MRRD1331 MRRD1376 PC6242 PC6249 PC6261 PC6264 PC6273 PC6277 PC6286 PPS16207 RF1647MR01 RF3314MR01 RU1115MR01 RU2144MR01 RU3261MR01 RU3611MR01 RU3926MR01 RU7180MR01 RU7872MR01 RU8891MR01 ZA1374MR01 (Updated 12/29/25 - Additional System IDs 83027826405518 83027210326718 83027600908419 83027006503017 83027001002910 83027009119914 83027200044913 83027607417021 83027606787616 83027602133220 RU6890MR02) (Updated 1/28/26 - Addl system IDs 505562MR01 00055MRS03 YE600109) (Updated 2/19/26 - Addl system IDs 83027104892617 R83027804641725 83027029471615 83027108785616 83027827006615) D. UDI-DI 00840682113786, System ID 8607632 8718381 04009MRS01 082427010169 082427010183 082427010186 082427010191 082427010203 082427020090 082427020091 082427020102 082427020104 082427020106 082427020119 082427020122 082427030179 082427030189 082427030190 082427030224 082427040287 082427040297 082427040300 082427040305 082427040314 082427040317 082427040340 082427060074 082427060091 082427060104 082427060107 082427060111 082427070238 082427070241 082427070246 082427070249 082427070251 082427070253 082427070266 082427070281 082427070301 082427070308 082427070329 082427080100 082427080108 082427080110 082427080112 082427080119 082427080120 082427080122 082427080126 082427080128 082427080130 082427080131 082427080134 082427080140 082427090343 082427090392 082427090394 082427090396 082427090402 082427090405 082427090407 082427090408 082427090409 082427090410 082427090416 082427090420 082427090422 082427090423 082427090425 082427090441 082427090444 082427090449 082427090458 082427090463 082427090484 082427090485 082427090492 082427100334 082427100382 082427100395 082427100403 082427100406 082427100410 082427100415 082427100429 082427100430 082427100434 082427100439 082427100440 082427100449 082427100455 082427100457 082427100471 082427100476 082427100478 082427100483 082427100494 082427100505 082427110095 082427110099 082427110101 082427110103 082427110145 082427110159 082427120229 082427120274 082427120278 082427120280 082427120283 082427120288 082427120291 082427120296 082427120300 082427120305 082427120307 082427120309 082427120319 082427120321 082427120325 082427120338 082427120366 082427150112 082427150135 082427150136 082427160266 082427160279 082427160282 082427160285 082427160287 082427160315 082427160320 082427160331 082427160337 082427160347 082427160370 082427170030 082427180063 082427180064 082427180065 082427180081 082427190137 082427190154 082427190164 082427190167 082427190172 082427190173 082427190176 082427190183 082427200166 082427200170 082427200181 082427200190 082427200195 082427200196 082427200204 082427210219 082427210224 082427210232 082427210244 082427210245 082427210263 082427220096 082427220117 082427230171 082427230174 082427230176 082427230177 082427230194 082427230201 082427230213 082427250091 082427250099 082427250105 082427250108 082427250109 082427250112 082427250129 082427250140 082427270072 082427270073 082427270074 082427270077 082427270081 082427270082 082427280031 082427290047 082427290053 082427290057 082427290063 082427300032 082427300033 082427310147 082427310158 082427310162 082427310167 082427310169 082427310177 082427310186 082427320003 0828270073 083027000767723 083027000768323 083027001117523 083027001417122 083027003253121 083027003379023 083027005964822 083027062604122 083027063940021 083027068027022 083027101854320 083027109354222 083027283729423 083027600102223 083027600102423 083027600560118 083027601272821 083027602480921 083027603618122 083027604659723 083027605752519 083027607811122 083027820524319 083027827469520 083027843834723 0850270506 0850270511 0850270532 0850270534 0850270545 0850270549 0850270557 0850270560 0850270563 0850270568 0850270569 0850270593 0850270594 0850270618 0850270634 0850270642 0850270643 0850270644 0850270647 0850270649 0850270653 0850270660 0850270663 0850270665 0850270666 0850270669 0850270670 0850270678 0850270679 0850270680 0850270682 0850270691 0850270692 0850270694 0850270696 0850270697 0850270701 0850270704 0850270711 0850270712 0850270716 0850270726 0850270727 0850270736 0850270738 0850270743 0850270744 0850270745 0850270746 0850270748 0850270749 0850270750 0850270751 0850270757 0850270759 0850270760 0850270761 0850270763 0850270766 0850270767 0850270768 0850270769 0850270770 0850270779 0850270782 08807712 1557MR0008 1557MR0019 1557MR0023 1557MR0029 1557MR0039 1557MR0040 1557MR0042 1557MR0046 1557MR0048 1557MR0055 1573MR0020 1573MR0040 1573MR0044 1573MR0046 1573MR0052 479397NUTEX 5512MR0026 5973MR0022 5973MR0023 5973MR0024 5973MR0025 5973MR0026 5973MR0027 5973MR0028 5973MR0031 5973MR0032 5973MR0050 5973MR0052 5973MR0053 5973MR0054 5973MR0055 5973MR0060 5973MR0061 5973MR0063 5973MR0064 5973MR0067 5973MR0068 5973MR0069 5973MR0072 5973MR0075 5973MR0076 5973MR0077 5973MR0079 5973MR0080 5973MR0081 5973MR0083 5973MR0086 6073MR0050 6073MR0056 6073MR0057 7982MR0016 7982MR0024 7982MR0026 7982MR0029 7982MR0036 7982MR0038 7982MR0039 7982MR0040 7982MR0045 7982MR0049 7982MR0053 7982MR0061 7982MR0084 7982MR0087 828210VETMR A102096603 A183022901 A183042901 A202346201 A210970803 A255223003 A487700002 A502257306 A5191113 A5239815 A556284805 A5623804 B215175012 DZ3898MR01 ET1238MR01 ET1239MR01 FPG86456 GH5235MR01 H6114MR04 HU1243MR03 HU1814MR01 HU1840MR01 IDMR54037401 JO4102MR01 JO4142MR01 JO4217MR01 JO4223MR01 KA2844MR01 KA2849MR01 KA3287MR01 KA3299MR01 KA3323MR01 KA3399MR01 KA3400MR01 LY1157MR01 MA1214MR01 MA1268MR01 MA1493MR01 MA1548MR01 MA1651MR01 MA1780MR01 MA1841MR01 MA1895MR01 ME3002MR02 MR00002 MR00013 MR00020 MR00024 MR00029 MR00041 MR00050 MR00055 MR00060 MR00061 MR00065 MR00067 MR00072 MR00073 MR00075 MR00076 MR00079 MR00085 MR00091 MR00117 MR00118 MR00132 MR00135 MR00139 MR2317PY MR3050AR MR3104AR MR44672701 MR4790AR MR50188321 MR50565031 MR50760571 MR51310631 MR51310811 MR6013AR MR6759CO MR6931AR MR9874AR MRR049 MRR088 MRR1004 MRR108 MRR10831 MRR1087 MRR10976 MRR11065A MRR11241 MRR11258 MRR11495 MRR11628 MRR1175 MRR1241 MRR131 MRR1333 MRR1397 MRR142A MRR1476 MRR1555 MRR1573 MRR1972 MRR2188 MRR2226A MRR2295 MRR2459 MRR2507 MRR2667 MRR2681A MRR2744 MRR276 MRR2825 MRR2844 MRR2924 MRR3211 MRR3433 MRR3439 MRR3509 MRR3558 MRR3579 MRR3590 MRR3619 MRR3633 MRR3652 MRR3673 MRR3705 MRR3730 MRR376 MRR3777 MRR4068 MRR412 MRR4141 MRR4146 MRR4434 MRR4488 MRR4788 MRR4972 MRR5040 MRR5143 MRR5150 MRR5157 MRR5178 MRR5666 MRR5747 MRR5749 MRR5800 MRR5941 MRR5942 MRR6333 MRR6425 MRR6531A MRR6655 MRR6939 MRR7385 MRR7419 MRR7759 MRR798 MRR8159 MRR8692 MRR974 MRRD0280 MRRD0302 MRRD0430 MRRD0464 MRRD0654 MRRD0661 MRRD0731A MRRD0903 MRRD0936 MRRD0949 MRRD0971 MRRD0985 MRRD0986 MRRD0991 MRRD1005 MRRD1007 MRRD1012 MRRD1032 MRRD1042 MRRD1049 MRRD1062 MRRD1070 MRRD1091 MRRD1097 MRRD1109 MRRD1126 MRRD1142 MRRD1149 MRRD1164 MRRD1168 MRRD1171 MRRD1183 MRRD1197 MRRD1430 MRYR2176 NG1042MR02 NG1048MR01 NG1377MR01 NG1746MR01 NG1868MR01 NG1951MR01 NG1978MR01 NG1991MR01 PC6137 PC6173 PC6230 PC6241 PC6245 PC6246 PC6247 PC6248 PC6253 PC6254 PC6258 PC6259 PC6260 PC6262 PC6263 PC6265 PC6267 PC6268 PC6269 PC6271 PC6274 PC6276 PC6278 PC6280 PC6281 PC6284 PC6287 PC6288 PC6290 PC6293 PC6298 PC6299 PC6302 PL0636MR01 R83027024266224 RF1053MR01 RF1075MR01 RF1194MR01 RO1114MR01 RO1118MR02 RO1459MR01 RO1508MR03 RO1511MR01 RO1523MR01 RO1530MR01 RO1588MR01 RO1629MR01 RU0731MR01 RU1117MR01 RU1140MR01 RU1242MR01 RU1757MR01 RU1826MR01 RU2711MR01 RU3158MR01 RU3192MR01 RU3232MR01 RU3315MR01 RU3639MR01 RU3930MR01 RU4355MR01 RU4670MR01 RU7310MR01 RU7612MR02 RU8782MR01 RU9155MR03 SA2846MR01 SZ0001MR01 UZ1001MR04 UZ1018MR01 UZ1063MR01 UZ1085MR01 UZ3009MR01 ZA3061MR01 (Updated 1/28/26 - Addl system IDs 850270510 850270531) (Updated 2/19/26 - Addl system IDs 1557MR0023 1557MR0015 83027000625010 R83027804647025 ) E. UDI-DI 00840682116114, System ID MR50547781 F. UDI-DI 00840682118576 System ID KA3284MR01 MRRD0220 G. 00840682118606 System ID MRYR2088 H. UDI-DI 00840682118934 System ID MA1528MR01 MR49897611 I. UDI-DI 00840682118989 System ID MR52294081 MR52673261 J. UDI-DI 00840682121729 System ID 7982MR0033 K. UDI-DI 00840682146814 System ID 083027106959123 083027218875120 0850270765 L. No UDI-DI System ID 214619LSFMR1 219845MR 254IDEALMRI 281840SIGNA 281AVSMR1 318386MR 360236MR1 360338BPMR 405418ERMR 412373MR 414289MR1 414973MR3 423643MR1 432520UOMR 440673MR 469500RCER 501941MR1 505587MR 505NUTEXMR 505VCAMR 520TMHMR 615230GPMR 615366APMR 615394BPMR 615467PGHMR 713330ADMR1 713425FMR1 720495MR 785NTEXCMR 830HILLMRI 832761MR1 850332MR 850SUMMITMR 903357RRMR1 903TECMR1 904272MR1 973227MR 985NUMRI 12248235 082427010113 082427010132 082427010137 082427010138 082427020074 082427020087 082427020098 082427030198 082427040230 082427040263 082427040342 082427060102 082427070181 082427070193 082427070338 082427070353 082427080143 082427090297 082427090306 082427090318 082427090320 082427090324 082427090450 082427090505 082427100302 082427100337 082427100362 082427100366 082427110168 082427120226 082427120230 082427120290 082427120308 082427120322 082427120324 082427130102 082427140146 082427140167 082427140344 082427160192 082427160195 082427160196 082427160206 082427160209 082427160214 082427160215 082427160216 082427160219 082427160255 082427160353 082427160362 082427170038 082427170041 082427180044 082427180049 082427190126 082427190127 082427190128 082427190133 082427190140 082427200191 082427200227 082427200234 082427200238 082427210178 082427210179 082427220054 082427220068 082427220105 082427220119 082427220137 082427230130 082427230132 082427230141 082427230206 082427230258 082427230262 082427240078 082427240096 082427240105 082427240121 082427250104 082427250110 082427250115 082427270062 082427270065 082427270066 082427280021 082427280022 082427280027 082427290056 082427290077 082427300036 082427310109 082427310168 083027006234424 083027025734024 083027042152022 083027048120322 083027048534221 083027062669515 083027065585821 083027065586021 083027068027121 083027068974017 083027105610324 083027106624723 083027201690622 083027211337724 083027216242724 083027246628424 083027280276023 083027283416824 083027285714122 083027600101523 083027601468324 083027605441924 083027608669123 083027608941024 083027609091523 083027609370421 083027801988324 083027802613524 083027821911618 083027822977324 083027823295623 083027826909223 083027826912823 083027841660621 083027842765222 083027842792322 083027843415723 083027843416323 083027844172423 083027845776823 083027848566822 083027848783117 083027862823022 083027865734924 0850270501 0850270735 0850270785 0850270790 0850270798 1553MR0069 1557MR0054 1557MR0062 1573MR0003 1573MR0071 1573MR0074 2830981MR 5973MR0012 5973MR0015 5973MR0088 5973MR0089 5973MR0090 5973MR0094 5973MR0101 7982MR0051 7982MR0065 9830MR0111 A339043902 C5201201 DZ2763MR01 DZ4681MR01 EG2795MR01 GON5393292 GON5460483 GON5462768 H19431MR05 IQ1872MR01 JO4140MR01 JO4216MR01 JO4239MR01 KA1121MR01 KA3098MR01 KA3126MR01 KRMR54388651 KRMR54531951 KRMR54944341 LB1456MR01 MA1148MR01 MA1516MR01 MA1540MR01 MA1649MR01 MA1883MR01 MA1908MR01 MR1766EC MR50241901 MR50413441 MR51128743 MR51992191 MR52317951 MR52673071 MR53130881 MR5497DO MR6257GT MR6941EC MR7765PY MRG2KS17002 MRR10693A MRR11181 MRR11272 MRR11313 MRR11497 MRR11573 MRR2675 MRR2802 MRR318 MRR3242 MRR3419 MRR370A MRR3785 MRR3970 MRR4005 MRR4983 MRR5020 MRR5182 MRR5629 MRR5695 MRR585 MRR5926 MRR6443 MRR669 MRR769 MRR981 MRRD0283 MRRD0373 MRRD0389 MRRD0400 MRRD0469 MRRD0482 MRRD0489 MRRD0978A MRRD1001 MRRD1108 MRRD1116 MRRD1138 NG1843MR01 NG1876MR01 NG1880MR01 PA1099MR01 PC5068 PC5080 PC6257 PC6296 PL3500MR01 RF0314MR01 RF0852MR01 RF0933MR01 RF0944MR01 RF1203MR01 RF2395MR01 RU3889MR01 RU3929MR01 RU4916MR01 RU7447MR01 RU7536MR01 RU9105MR01 RU9636MR01 RW1049MR01 SA1064MR02 UZ1099MR01 UZ1320MR01 UZ1321MR01 UZ1353MR01 VNMRI24515758 VNMRI24660439 VNMRI24808271 (Update 12/29/25 - Additional System IDs 83027242389615 EG2558MR02 83027600019013 83027862672815 83027201013310 83027208006511 83027044291311 83027608347414) (Update 1/28/26 - Addl system IDs 850270476 850270480) (Update 2/19/26 - Addl System IDs 83027281851225 416431MR KRMR55101211 MR00318 82427110157 82427320004 82427080132 R83027864638824) 2. Explorer A. UDI-DI 00195278124609 System ID RS4012MR01 B. UDI-DI 00195278577221 System ID 8224770 8264764 02806189 07816651 0835270023 0835270028 09632508 09865187 48010MRS02 6444MRDICO CRMR01 DPD37900 H7024MR06 LB1064MR02 MR00144 MR00149 MR00173 MR00176 MR00177 MR00178 MR00181 MR00205 MR00206 MR00209 MR00212 MR00213 MR00214 MR00215 MR00220 MR00222 MR00233 MR00234 MR00235 MR00239 MR00240 MR00241 MR00246 MR00253 MR00266 MR00276 MR1110AR MRR10597 MRR9706 MRR9917 MRRD1323A MRRD1434 MRRD1436 MRRD1437 MRRD1447 MRRD1449 MRRD1453 MRRD1457 MRRD1462 MRRD1465 MRRD1481 PC0058 PL0631MR01 VNMRI24808273 YM1476 ZA2101MR02 ZA2145MR02 ZA2614MR01 C. UDI-DI 00840682104401 System ID 00313MRS03 D. UDI-DI 00840682113762 System ID 2533 2647 1202522 2668464 2708848 2728519 6098456 6225296 6242121 6968494 7210650 7461157 8282959 8495586 8526228 9435702 9826031 83207359389 83212927900 83215453018 00577MRS02 00824MRS01 01071MRS01 06051MRS01 06236MRS01 07023MRS01 07023MRS02 082427020111 082427040254 082427060088 082427060092 082427090362 082427090373 082427090393 082427090401 082427100396 082427120214 082427160302 082427210191 082427240095 0828270069 083027000004112 083027004267914 083027006678722 083027021879815 083027022546321 083027024122521 083027026468322 083027026592420 083027042434320 083027042722321 083027210326718 083027242173520 083027280009412 083027600426022 083027600426222 083027601746512 083027602133220 083027606532922 083027608479920 083027609288917 083027800189520 083027802635819 083027806086120 083027820038511 083027820801321 083027821188412 083027823263019 083027826697920 083027827198515 083027827461917 083027841233721 083027841239321 083027842020719 083027842855011 083027842901111 083027844318723 083027846984620 083027848070318 083027860008512 083027865910620 0834270014 0835270003 0835270005 0835270016 0835270018 0835270029 0835270035 0835270036 0850270108 0850270132 0850270165 0850270187 0850270214 0850270219 0850270254 0850270267 0850270269 0850270288 0850270344 0850270353 0850270372 0850270376 0850270396 0850270431 0850270441 0850270443 0850270519 0850270522 0850270525 0850270526 0850270527 0850270544 0850270548 0850270551 0850270552 0850270554 0850270555 0850270558 0850270613 0850270614 0850270747 0853270216 0856270043 0856270045 0856270054 11670MRS01 124454MR01 126548MR01 14008MRS01 1553MR0009 1553MR0012 1557MR0050 1557MR0051 1573MR0011 1573MR0022 1573MR0026 160234MR01 17014MRS01 19013MRS01 20001MRS02 20017MRS01 220112MR01 233637MR01 25018MRS01 25018MRS02 26024MRS01 2697548EXCITE 2726108MRHD 2774243SIGNA 2812553GOLD 2824773LX 2842546BEXCITE 2883683SIGNA 303355MR 305682MR1 31029MRS01 31041MRS01 316689MR 34241MRS01 34308MRS01 35118MRS01 352344MR2 360937MR01 40009MRS01 41044MRS01 412784MR1 415723SHMR6 445MR2 46014MRS02 482180SIGNA 501030MR02 505168MR01 519759MR01 54003MRS01 55018MRS01 55038MRS01 5512MR0024 560776MR01 560776MR02 5973MR0029 5973MR0035 5973MR0036 5973MR0039 5973MR0041 5973MR0043 5973MR0049 5973MR0062 5973MR0066 5973MR0098 600100MR04 600118MR02 6073MR0025 6073MR0026 6073MR0040 61022MRS01 631485MR01 70383MRS03 70383MRS04 71010MRS01 712330MR01 716839MR1 718250MR 79004MRS02 824158MR01 833MR000001 A103421315 A1279217 A129101307 A215175013 A23086005 A377686701 A5102656 A5157407 A5161411 A5203406 A5218932 A5247924 A5276812 A5300112 A5327026 A5355209 A5359620 A5395312 A5697806 A5712303 A5738503 A5811749 AL4093MR01 ANGELLMR1 B215175025 B75162215 BA4147MR01 BG4612MR01 BR93131XXX C5126838 C5410301 CO3030MR02 DK1083MR03 DPD23001 DPD59704 DPN34709 DPN47008 DPN62302 DZ1406MR03 DZ3484MR01 DZ3953MR01 DZ4149MR01 DZ4258MR01 DZ4313MR01 DZ4483MR01 EG1005MR03 EG2920MR01 EG3010MR01 ET1021MR01 ET1021MR02 ET1296MR01 FPD27500 FPG23603 GPX22600 H1141MR24 H17646MR04 H17660MR3 H2126MR16 H3044MR01 H3943MR01 H41223MR02 H42261MR01 H4676MR03 H5382005 HAMB02MR01 HC9027MR02 HU1672MR01 HU1749MR01 HU1831MR01 HU1835MR01 HU1842MR01 IR2103MR01 IR2312MR01 IR2376MR01 JO1002MR04 JO4109MR02 K2308 KA1029MR01 KA1040MR01 KA2801MR02 KA2824MR01 KA3109MR01 KA3260MR01 KA3300MR01 KA3355MR01 KA3377MR01 KA3378MR01 KA4008MR01 L2202007 LY1011MR02 LY1175MR01 M1265006 M189104208 M222271601 M2321310 M24313809 M2485631 M2533237 M2844564 M2848451 M347028307 M414406701 M4183856 M4204524 M4497429 M6015639 M9886878 MA1087MR01 MA1219MR01 MA1263MR01 MA1727MR01 MA1818MR01 MA1881MR01 MA1955MR02 ME208331 MEDSMR1 MP324987 MP385511 MP825711 MPX98004 MR00003 MR00011 MR00014 MR00016 MR00023 MR00030 MR00031 MR00034 MR00035 MR00036 MR00044 MR00047 MR00048 MR00052 MR00053 MR00054 MR00059 MR00062 MR00063 MR00068 MR00092 MR00095 MR00097 MR00098 MR00106 MR00107 MR00108 MR00113 MR00122 MR00125 MR00126 MR00127 MR00128 MR00131 MR00133 MR00142 MR00148 MR1196AR MR1205CO MR1245AR MR1437AR MR306092MR8 MR3403AR MR3630CO MR3718AR MR3766AR MR3867AR MR4038CL MR4574CO MR46599621 MR48271631 MR49554941 MR49966381 MR50004041 MR50061091 MR51028131 MR51420931 MR5150AR MR51796811 MR51941821 MR52113731 MR5218EC MR52293211 MR52298831 MR52299021 MR52300401 MR5239AR MR52673481 MR52743961 MR5368CO MR54101042 MR5444AR MR5700AR MR6459AR MR7077AR MR7206AR MR7856AR MR7906AR MR8006CO MR8229AR MR8433AR MR8464CL MR8785AR MR8830AR MR8920AR MR9679AR MRR10073 MRR10084 MRR10144 MRR10359 MRR10826 MRR10845 MRR10899 MRR10995 MRR11087 MRR11223 MRR1134 MRR11372 MRR11494 MRR11562 MRR11618 MRR11630 MRR11640 MRR2714 MRR4116 MRR8057A MRR8090 MRR8517 MRR8605 MRR8837 MRR9306 MRR9674 MRRD0470 MRRD0536 MRRD0868 MRRD0909 MRRD0924 MRRD0927 MRRD0952 MRRD0958 MRRD0996 MRRD0997 MRRD1002 MRRD1020 MRRD1037 MRRD1076B MRRD1081 MRRD1122 MRRD1157 MRRD1175 MRRD1180 MRRD1181 MRRD1213 MRRD1232 MRRD1233 MRRD1242 MRRD1254 MRRD1279 MRRD1283 MRRD1287 MRRD1291 MRRD1311 MRRD1317 MRRD1321 MRRD1324 MRRD1332 MRRD1335 MRRD1347 MRRD1357 MRRD1363 MRRD1370 MRRD1380 MRRD1383 MRRD1389 MRRD1400 MRRD1407 MRRD1410 MRRD1411 NG1256MR01 NG1359MR01 NG1739MR01 NG1743MR02 NG1915MR01 NO1021MR02 O011MR02 P00027MR01 P00224MR02 P00304MR01 P00329MR01 P00360MR01 P00403MR01 P00477MR01 PC0033 PC0040 PC0045 PC0055 PC0081 PC0218 PC0396MR04 PC0396MR10 PC0702MR01 PC0822 PC0824 PC0836 PC0840 PC0843 PC0854 PC0921 PC0924 PC1351MR01 PC1455MR01 PC4036MR01 PC5009 PC5058 PC5995MR01 PC6011 PC6055 PC6128 PC6145 PC6152 PC6153 PC6178 PC6181 PC6191 PC6206 PC6223 PC6231 PC6235 PC6236 PC6239 PC6243 PC6244 PC6250 PC6251 PC6252 PC6255 PC6266 PC6272 PC6279 PC6282 PC6283 PC6285 PC6289 PC6292 PC6294 PC6295 PC6297 PC6300 PC6301 PK1453MR01 PK1623MR01 PL0439MR02 PL0620MR02 PL0659MR01 PL0677MR01 PL1316MR01 PL1355MR01 PL1709MR02 PL1720MR01 PL1730MR03 PL1787MR01 PNUE04MR01 PNUE06MR01 PNUE07MR01 PPR23104 PPR29115 PPR92403 PPR96413 PPS18202 PPS32605 PPS49012 PPS80401 PX4178MR01 PX4178MR02 R83027603617222 R83027843424622 RF0567MR01 RF1283MR01 RF1352MR01 RF1695MR01 RF1749MR01 RF1911MR01 RF3042MR01 RO1060MR02 RO1122MR01 RO1150MR01 RO1210MR01 RO1231MR02 RO1272MR01 RO1362MR01 RO1428MR01 RO1544MR01 RO1562MR02 RO1572MR01 RO1577MR01 RO1584MR01 RO1593MR01 RO1595MR01 RO1598MR01 RO1602MR01 RO1622MR01 RO1646MR01 RO1678MR01 RS4032MR02 RU1017MR02 RU1017MR03 RU1078MR01 RU1204MR04 RU2447MR01 RU2652MR03 RU4454MR01 RU5552MR01 RU6177MR01 RU7545MR02 RU7550MR01 RU7618MR01 RU7884MR01 SA1056MR01 SY1012MR02 TN1018MR02 TP0008MR02 TP0010MR01 TP0011MR01 UZ1344MR01 UZ1357MR01 UZ1358MR01 UZ1359MR01 UZ1360MR01 X116370513 X121122503 X178185401 X185801209 X225779101 X226587717 X669977018 X706835017 X756087033 YM3092 YP567303 Z001MR02 ZA1000MR04 ZA1006MR03 ZA1017MR01 ZA1038MR02 ZA1560MR01 ZA2100MR01 ZA2103MR03 ZA2119MR02 ZA2224MR02 ZA2250MR01 ZA3049MR01 (Updated 12/29/25 - Additional System IDs MRRD0541 83027068974017 83027809746318 83027820034810 83027200013113) (Updated 2/19/26 - Addl System IDs 12218985 AE1485MR01 ¿PPR10411 ET1296MR01 7982MR0012 DZ1406MR02 JO1029MR02) E. UDI-DI 00840682113786 System ID 083027061463720 083027102101447 083027602101609 083027800190520 083027842583917 0850270667 B197656404 FPG08204 FPG10102 MPD20500 MR1914CL MR1936AR MR4330AR MR4479CO MR5061CL MRR1946 MRR2425 MRR2854 MRR8531 MRRD0950 MRRD0969 MRRD1050 MRRD1085 MRRD1090 MRRD1159 PL0439MR01 R83027064146723 R83027603868323 R83027604013623 R83027824110923 R83027844030823 R83027844086323 R83037844277224 (Updated 2/19/26 - Addl System IDs R83027604645625 R83027804637924 R83027024637324 INMRI26411977 R83027604643725 R83027824646325 INMRI26498070 INMRI26498071 INMRI26760338 INMRI26775782) F. UDI-DI 00840682118576 System ID MR51928441 G. UDI-DI 00840682118583 System ID KA3466MR01 H. UDI-DI 00840682118606 System ID MR51028551 I. UDI-DI 00840682118958 System ID 1344119 MR47780703 MR48582681 MR50497271 MR52096141 MR52293331 MR52293461 MR52298391 MR52353941 UA4410MR01 UA4810MR01 UK1006MR01 (Updated 2/19/26 - Addl Systems EG1126MR01) J. UDI-DI 00840682118996 System ID MA1955MR01 MR50554841 MRR11499 K. UDI-DI 00840682138239 System ID EG5723US04 L. UDI-DI 00840682145770 System ID PC6195 M. UDI-DI 00840682146814 System ID 083027006661822 083027212212422 083027289046323 083027803478322 083027804647721 0850270151 0850270485 CP749713 M200598212 MR2527CL MRR10957 MRR1120 MRR8034 R83027864142823 N. No UDI-DI System ID 201656MR 203576MR2 205280MR1 210297SLMR 210804SUNMR 212305MR6 215VETMR 219435MR 253219RMR 253833CMR 256MIMR 260266MR 260469FCMR 303762MR 303794MR 307352MR 307789MR 307SUMMITMR 312355CVMR 312CCHMR2 314644IMR1 315470MR 323441MR1 323441MR2 323441MR3 334222MR 352401MR 352VAMR1 401333RIMR 402384MNMR 406721MBJMR 406863WMR 407351MR 407HSMR 407OSCMR 407PIMRKCH 423626MR 425823EMR 425879CDIK 469420EMMR1 478743MR 478ORTHOWRMR 479936MRHOG 480425MR7 501977SVMR 503540MR1 503656MR 508746JMR2 510734MR 512ASOPMR 512RRORTMR 515294MR 518262MR3 541677MMR 570552MR 570552MR2 603650HDX 606451MRI 615320MR1 618242OMR 619291MR1 630208DMR 630393CMR 631444MR01 631444MR02 661CBCCMR 678474JCMR 702228LXMR 702255MR 703369MR2 708747OFMR 716633MR1 718567MR 727869MR 740393MR 765473MR 773327COMR 785738MR 801KINGMR1 801NEUROMR 802334MR360 804747LXMR 805681MR1 806212LX2 806792NEUROMR 812825MR1 813436MR 813972MR2 830643MMR 830643MMR2 843777EXPE 843839MR 865687MR1 903463TNMR1 907VNSMR 912557MR 912644MRI 913588WWMR 915595MR1 916787MR 940484DMR 941342MR 941624MR 956389VBMR2 970927MR 972334EFMR1 972548MR1 972579TSMR1 972932KAUFMR1 979830BCMR 979MGMR1 ALLIANCESIG496 MRGSSIG410 RIMIMR SHIMR02612 SMSVIT4 33262 34574 60357 1167491 1292548 1347499 2599138 2626827 2682131 2705171 2705318 2713328 2713415 2849423 2850446 9447742 11854698 12761803 00136MRS02 02834124 082427030138 082427040203 082427070277 082427090305 082427090323 082427140179 082427160225 082427160238 082427190139 082427190143 082427220077 082427230145 082427240074 082427290030 0828270048IB01 083027046625721 083027100019412 083027100049812 083027103536122 083027200753416 083027207170016 083027207969111 083027209389215 083027280565115 083027600007311 083027600019013 083027600865518 083027600908419 083027600909023 083027601151217 083027602481524 083027603806711 083027606048519 083027606787616 083027607457016 083027609619023 083027800853915 083027801749622 083027801967722 083027802614121 083027803370924 083027806275019 083027822898921 083027840149222 083027840855323 083027843218922 083027843759323 083027844800321 083027846535119 083027860044912 083027863759523 083027863759923 083027864867814 0835270002 0835270019 0835270020 0835270024 0843270008 0843270017 0847270029 0850270111 0850270159 0850270184 0850270200 0850270247 0850270326 0850270463 0850270500 0850270505 0850270562 0850270789 0853270224 0856270051 0856270055 0856270057 0856270073 0910272080 0910272087 0910272089 115030MR01 123702MR03 1557MR0041 1557MR0045 202707978HD 212305MR6 219435MR 24501195MR-1 24527633818MRI 2566917SIG15T 2567464SIGNAMR 2586967SIGNA 2605060SIGEXT 2624537EXCITE 264EXCHDE 2719697HD 2722SIGNA15 2806308HD 2867718MRHDE 2867727HDE 2880725MR 31039MRS01 312355CVMR 34787MRS01 38210315MRI 38803561MRMET 3882647967MROCC 3882857623MRCTR 3882936037MRAND 393115MR01 396399MR02 418691MR 420127MR02 423626MR 48005MRS01 487692MR01 48MRE2744667 505560MR01 604822MRTS 630208DMR 63028MRS01 67019MRS01 70001MRM01 71009MRS01 719383MR 780964EXP 787263HDX 787840EXCITE A5274202 A5405213 A5437701 A5761301 A6470604 AE1160MR01 BG4600MR01 C018MR01 CC5340MR02 CUCMR1 DPN34709 DZ1027MR01 DZ1035MR03 DZ1297MR01 DZ1406MR01 DZ1560MR01 DZ1638MR02 DZ2361MR01 DZ2773MR01 DZ3165MR01 DZ3365MR01 DZ3741MR01 DZ4165MR01 DZ4227MR01 DZ4380MR01 DZ4609MR01 EG1196MR01 EG1279MR01 EG1284MR02 EG1542MR01 EG1709MR01 EG1783MR02 EG1790MR02 EG1929MR02 EG1990MR01 EG2557MR02 EG2604MR01 EG2940MR01 EG2948MR01 EG3013MR01 EG3149MR01 FE387840 FEC800352 FI1041MR01 FI1064MR01 FI1502MR01 FPD40200 GF1007MR01 GON5275711 GON5330477 GON5424796 GON5427511 GON5441497 GON5443004 GON5449341 GON5454232 GON5457519 GON5472583 GON5474299 GON5481647 GON5484177 GON5498274 GON5499500 GON5499503 H10651MR06 H17659MR1 H17666MR1 H1787MR11 H1926MR05 H2026MR13 H4079MR03 H41222MR02 H4262MR05 H4352MR05 H44432MR01 H4767MR02 H5531MR01 H55722MR02 H7247MR01 HBLUCOMR01 HC0628MR01 HCVMMR1 HU1583MR01 HU1641MR01 HU1744MR01 HU1897MR01 HU2012MR01 HXXXXX07 IQ1666MR01 IR1904MR01 IR2050MR01 IR2344MR01 IR2510MR01 IR2513MR01 IR2517MR01 IR2567MR01 IS1006MR01 K001MR01 K002MR01 KA1033MR01 KA3416MR01 KRMR54892201 KW1005MR02 KW1006MR02 LT4069MR01 LV4026MR02 LY1011MR01 LY1013MR01 LY1160MR01 LY1177MR01 M1265008 MA1003MR01 MA1020MR02 MA1047MR01 MA1151MR01 MA1197MR01 MA1233MR01 MA1252MR02 MA1278MR01 MA1296MR01 MA1460MR02 MA1479MR01 MA1488MR01 MA1502MR01 MA1588MR01 MA1650MR01 MA1711MR01 MA1737MR01 MA1769MR01 MA1864MR01 MA1938MR01 MA1941MR01 ME051539 MEX71105 MEX71200 ML1013MR01 MP118827 MP750816 MPX43106 MPX43803 MR00153 MR00257 MR00265 MR1355680 MR2582DO MR287078MR0 MR3338AR MR47289841 MR48982456 MR51201071 MR51359221 MR51928451 MR51928461 MR53770811 MR54068981 MR54707061 MR7065BO MRG2YS13039 MRHM0503 MRR0455 MRR10160 MRR10328 MRR10744 MRR10813 MRR10855 MRR10892 MRR10989 MRR11031 MRR11177 MRR11178 MRR11187 MRR11547 MRR11558 MRR11626 MRR1183 MRR1560SX2 MRR3140 MRR4342 MRR4548A MRR5840 MRR5954 MRR6466 MRR6664 MRR7716 MRR8311 MRR8394 MRR8562 MRR8639 MRR9230 MRR9466 MRR9546 MRR97761 MRR9885 MRR9946 MRRD0405 MRRD0419 MRRD0595 MRRD0914 MRRD0988 MRRD1004 MRRD1139 MRRD1172 MRRD1260 MRRD1356 MRRD1468 MT1014MR01 N006MR01 NG1934MR01 NG1982MR01 NO1284MR01 OM1020MR01 OM1139MR01 P00020MR01 P00224MR01 P00605MR02 P00665MR01 PA0148MR01 PC0056 PC0072 PC0075MR03 PC0092 PC0099 PC0100 PC0125MR03 PC0201 PC0210 PC0345MR02 PC0573MR02 PC0612 PC0631 PC0813 PC0815MR03 PC0816 PC0817 PC0872 PC0910 PC0912 PC1401MR01 PC2007MR01 PC3827MR03 PC3885MR01 PC4537MR02 PC5004 PC5012 PC5030 PC5065 PC5075 PC5081 PC6021 PC6050 PC8740MR01 PER01511 PER18426 PK1314MR01 PK1390MR01 PK1391MR01 PK1627MR01 PK1628MR01 PK1629MR01 PL0001MR01 PL0589MR01 PL1016MR01 PL1107MR02 PL1493MR01 PL1501MR04 PL1745MR01 PL1754MR01 PL1755MR01 PL1760MR01 PL1776MR01 PL1813MR01 PL1822MR01 PL2256MR03 PL2309MR01 PL3331MR01 PL3594MR01 PL3927MR01 PPR10411 PPR59000 PPR62007 PPS26404 PPS62102 R83027064161124 R83027103776223 R83027243887423 R83027244627724 R83027803164322 R83027804089223 R83027804630424 R83027843920923 RF0252MR01 RF1883MR01 RF2406MR01 RF3270MR01 RF3661MR01 RF3834MR01 RF3863MR01 RF3864MR01 RF3955MR01 RO1160MR01 RO1172MR01 RO1184MR01 RO1194MR01 RO1198MR01 RO1227MR01 RO1640MR01 RO1644MR01 RO1664MR01 RO1673MR01 RO1674MR01 RO1675MR01 RS4001MR01 RS4019MR01 RS4043MR01 RS4052MR01 RS4124MR01 RS4156MR02 RTD0123 RU1653MR02 RU2157MR01 RU3259MR02 RU3291MR01 RU3754MR01 RU3923MR01 RU4898MR01 RU4916MR01 RU6261MR02 RU7524MR01 SA1012MR04 SA1012MR05 SA2161MR01 SA2191MR01 SA2485MR01 SD1057MR01 SD1080MR01 SD1081MR01 SD1084MR01 SD1088MR01 SD1094MR01 SY2013MR02 SY2074MR01 SY2077MR01 SY2078MR01 TN2004AW02 TP0009MR01 UZ1306MR01 UZ1316MR01 UZ1352MR01 YM0834 YM1745 YM3091 YP170A26 ZA1284MR01 (Update 12/29/25 - additional system ID HC1711MR01 817347PMCMR1 850270466) (Update 1/28/26 - Addl system IDs 850270482 850270433) (Update 2/19/26 - Addl system IDs 83027282542615 PC0906 82427040223 835270040 6073MR0001 JO1029MR02 83027209918410 R83027104645225 83027826645811 83027820006912 83027862101167 83027801497116 INMRI27005065 INMRI26760340 835270015 MA1272MR01 GON5488192 GON5499503 GON5499500 GON5498274) O: UDI: 01008406821137621118030021MNEXP1800062TJ, System ID ZA1374MR01 (Updated 2/19/26: 1.5T 30.0 Upgrade for Creator/Explorer System IDs GON5488192 GON5499500 GON5498274)
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 Commerce2538
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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