FDA · Medical device recall

SIGNA Creator… and 4 more products

March 5, 2025 Class II

Date: March 5, 2025
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: GE Healthcare (China) Co., Ltd.
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.
Distribution pattern: Domestic US distribution nationwide. International distribution worldwide.

5 products in this recall

SIGNA Creator…

Product: SIGNA Creator, SIGNA Explorer, NMRI systems
Quantity: 2538
Codes and lots: 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…
Recall started: Jan. 31, 2025
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: On 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.
Recall number: Z-1239-2025

Brivo MR355…

Product: Brivo MR355, NMRI system
Quantity: 22
Codes and lots: Brivo MR355 (No UDI) System IDs 082427010096 082427020046 082427040126 082427070076 082427070077 082427070170 082427100245 082427120151 082427180030 082427210147 082427210148 082427220025 082427220045 082427230060 082427240060 082427310104 0856270058 0856270059 MRR10200 MRR9920 RU1063MR03 RU8902MR01 (Updated 12/29/25 - Additional System ID 83027805544513) (Updated 1/28/26 - Additional System IDs: 82427220047 82427240055 82427070163 82427060068 82427140137 82427010122 82427280018) (Updated 2/19/26: Additional System ID EG1736MR02)
Recall started: Jan. 31, 2025
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: On 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.
Recall number: Z-1240-2025

Optima MR360…

Product: Optima MR360, NMRI system
Quantity: 33
Codes and lots: A. UDI-DI 00840682113762 System ID 0910274038 B. No UDI-DI System IDs 082427040134 082427040185 082427060043 082427070088 082427070093 082427070099 082427100174 082427100178 082427100197 082427120140 082427140095 082427220046 082427270041 082427310088 082427310092 083027288790310 0856270061 AE1373MR01 DZ1339MR03 FI1432MR01 H4678MR04 MRR9282 MRR9877 PL2059MR01 PL2433MR01 RU3338MR03 SA1056MR03 SA2191MR04 SA2253MR01 SA2352MR01 TN1008MR01 TN1241MR01 34352MRS01 (Update 12/29/25 - Additional System IDs 83027809699615, LV4026MR01) (Update 1/28/26 - Additional System ID 82427190104)
Recall started: Jan. 31, 2025
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: On 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.
Recall number: Z-1241-2025

Signa Mr355…

Product: SIGNA MR355, SIGNA MR360, NMRI system
Quantity: 241
Codes and lots: 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)
Recall started: Jan. 31, 2025
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: On 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.
Recall number: Z-1242-2025

Signa Mr380…

Product: SIGNA MR380, NMRI system, Non-US Only
Quantity: 188
Codes and lots: 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)
Recall started: Jan. 31, 2025
Device type: System, Nuclear Magnetic Resonance Imaging
Root cause (FDA): Software design
What the company told customers: On 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.
Recall number: Z-1243-2025

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1239-2025, Z-1240-2025, Z-1241-2025, Z-1242-2025, Z-1243-2025. The agency record governs; check it and the company before acting.

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