Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, S...

FDA Device Recall #Z-1305-2015 — Class II — March 9, 2015

Recall Summary

Recall Number Z-1305-2015
Classification Class II — Moderate risk
Date Initiated March 9, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Healthcare
Location Waukesha, WI
Product Type Devices
Quantity 9,369 (2,937 US, 6,432 OUS).

Product Description

GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

Reason for Recall

GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution including PR, GU and DC., and to the countries of: ALBANIA. ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DLVOIRE, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY. GHANA, GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAHHSTAN,KENYA,REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMA N,PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SIERRA LEONE, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UGANDA , UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM and ZAMBIA.

Lot / Code Information

Mfg Lot or Serial # System ID 00000301098MR0 AL4023MR01 AL4004MR01 AL4009MR01 00000346726YM3 DZ1004MR01 000000HDMR5247 DZ1009MR02 00000267807MR6 DZ1057MR01 00001251FMM01J DZ1006MR01 00000305201MR6 DZ1101MR01 000000HDMR6342 DZ1250MR01 00000002790M24 DZ1396MR01 00000000175M20 DZ1102MR01 00000311125HM9 DZ1072MR01 00000004368M27 DZ1547MR01 00000003534M25 DZ1339MR02 00000005640M28 DZ1339MR01 00001010BD6611 DZ1090MR01 00000015868GQ3 DZ1259MR01 00001011BD667C DZ1005MR01 00000272532MR3 DZ1193MR01 00000005809M29 DZ1598MR01 00000311119HM2 DZ1061MR01 000000HDMR5358 DZ1260MR01 00000290691MR5 DZ1261MR01 00000172500MR1 DZ1033MR02 00000004987M24 DZ1064MR02 00000005787M27 DZ1204MR01 00000009356GQ7 DZ1128MR01 00000306373MR2 DZ1525MR01 00000005637M24 DZ1605MR01 00000099206HM5 DZ1149MR01 00000180852MR6 4406SIGNAMRI 00000002740M29 MRR8513 00000291189YM9 34874SIGNA 00000005153M22 MRR9924 00000147993MR0 132HORIZON 00000305908MR6 MRHM0559 00000305909MR4 MRHM0560 00001011BD6688 16683THDX 00000006310M27 MRR9946 00000301223MR4 2918179MR 00000012619GQ3 4954MR15T 00000011311GQ8 2214SIGNA15 000000000Z001A 221SIGCONT 00000939BD5F5E 2835341HDX 00000014403GQ0 4365SIGNA15 00000012946GQ0 4127SIGNA15 00000014002GQ0 4732SIGNAHDX 00000010316GQ8 4786SIGNA15 00000290572MR7 4867SIGEXC1 00000332881HM2 MRR9196 00000004700M21 MRR9081 00000193354MR8 17SIGNACVI 00000170215MR8 482180SIGNA 00000340717HM8 MRR9358 00000001413M24 2906536HDE 00000332884HM6 MRR9174 00000070159MR9 71727SIGNAGS 00000000471M23 221HORIZONLX 000000000R3122 MRR3122 00000015549GQ9 4291EXC15T 00000082246MR0 6124SIGN05 000000HDMR6209 422SIGNA3T 00001308FMM01X MRHM0774 00000147586MR2 2722620SIG15 000000000R4968 4224INFINITY 00000346339HM5 MRR9496 00000000045M25 264EXCHDE 00000004105M23 MRR9061 00000440464YM6 341CONTOUR 00000088583MR0 4224SIGN15 00000015657GQ0 341SIGNA15 00000291190YM7 90CONTOUR 00000005526M29 MRR9669 00000340794HM7 MRR9372 00000088108MR6 1253SIGN05 00001309FMM08P MRUA0343 000000000R4601 MRR4601 00000360302HM4 MRR9725 00000124312HM0 4821PROF 00000127836HM5 4127PROF5 00000127838HM1 2322PROFILE 00000139823HM9 2637068PROEX 00000144315HM9 4832PROFILE 00000146546HM7 3783TCPROFILE 00000155614HM1 2644212PROEXC 00000161775HM2 2974PROFILE 00000162013HM7 381452PROEXC 00000162757HM9 2944PROFILE 00000164001HM0 378PROFILE 00000165746HM9 2688289PROF 00000167867HM1 4637PROFILE 00000169093HM2 4656PROFILE 00000169839HM8 2716760PRO 00000173927HM5 2715407SIGNA 00000190360HM8 3442PROFILE 00000190928HM2 4664PROFILEA 00000191140HM3 106PROFHD 00000200586HM6 27454PROF 00000200905HM8 3752PROFILE 00000203041HM9 1871PROFHD 00000220572HM2 422PROFILE 00000223184HM3 4291PROF3 00000237538HM4 2965PROIDECH 00000239006HM0 2861360PRO 00000242122HM0 34874PROF 00000262864HM2 2840304PROF 00000263642HM1 2901849MR 00000268655MR8 341OVATION 00000378053YM3 174288PROF 00000267463MR8 0910272012 00000000858M21 0910272073 00000167474MR6 0910273016 00000113894MR0 0910273009 002003-0811-08 0910272041X 00000163869MR1 0910272025 00000254376MR7 0910272059 00001236FMM012 0910272093 00000303451MR9 0910272085 00001011BD663A 0910272072 00000014419YR6 0910272075 00000013616GQ8 0910272047 00000216270MR9 0910272035 00000291429MR9 0910274032 00000280725MR3 0910274012 00000010570GQ0 0910274016 00001309FMM04B 83109684989 00001406NMM0AU 83115138353 00000005683M28 83101071304 00000006230M27 83114336196 00000001528M29 0910273042 00000014860GQ1 0910274026 00000145162MR4 0910272020 00000003099M29 0910272088 00000014688GQ6 0910274021 00000011438GQ9 0910273039 00000283546MR0 0910273026 00001203FMM0VW 0910273043 00000278795MR0 0910273029 00000280570MR3 0910273001 00000001808M25 0910273041 00000269041MR0 0910272044 00000296056MR5 0910277004 00000000167M27 0910272060 00000072679YM4 0910274002 00000159114MR8 0910272023 00000914BD5A88 0910272041 00000212850MR2 0910272034 00000292389MR4 0910272057 00000265594MR2 0910273028 00000278750MR5 0910273031 00000016295GQ8 0910272063 00000162196MR0 0910272038 00000168591MR6 0910273034 00000012697GQ9 0910277002 00000013755GQ4 0910275007 00000287641MR5 0910275003 00000299229MR5 AH5824MR01 00000210563HM3 AP6816MR01 00000293806HM6 AZ4010MR01 00000264740MR2 AZ1003MR01 00001308FMM043 AZ4029MR01 00000295711HM6 AZ4004MR01 00000308926HM5 AZ4015MR01 00000004957M27 AZ4030MR01 00000005154M20 AZ4027MR01 00000015843GQ6 AZ4002MR01 00001308FMM02N BH1017MR01 00000000356M26 BY4126MR01 00001106XF5036 BY4033MR01 00001139FMM0D7 BY4160MR01 000000HDMR5364 110028MR01 00000016312GQ1 110028MR02 00000290310MR2 030022MR01 000000HDMR5233 110037MR02 00000268122MR9 110037MR01 00000260628MR3 2560124 00000003979M22 MRR9112 00000521063YM8 36493057MR 00000002791YR2 46647374MR1 00001009BD6557 BA4080MR01 00000000998M25 BA4008MR01 000000000R7598 BA4105MR01 00000001693M21 BA4095MR01 00000001121M23 BA4086MR01 000000000R7609 BA4017MR01 00000276493MR4 BA4073MR01 00000006036M28 MRR9877 00000003391M20 MRR8777 00000001177M25 MRR7716 00000001042M21 2849423 00000290039MR7 2730504 00000012532GQ8 MRR1733 00000002229M23 MRR8295 00000300812MR5 MR14604YR3 00000521008YM3 47920 00000000437M24 2823686 00000014673GQ8 2659961 00000012974GQ2 1175978 00000000HM0842 MRHM0842 00000440430YM7 56531 00000002208M27 MRR8258 00000003388M26 MRR8311 00000001026M24 2868604 00000016190GQ1 2767341 00000298840MR0 MRR7919 00000002170M29 MRR8247 00000264747MR7 1155607 00000278211MR8 2651970 00000015624GQ0 2745073 00000015318GQ9 1238481 00000000181M28 2819277 00000016127GQ3 2713162 00000000072M29 2794606 00000002291M23 MRR8289 00000003302M27 MRR8519 00000137609MR4 39760 00000272335MR1 MRR4935 00000016264GQ4 2742309 00001009BD659A 2842277 00000000416M28 1324655 00000001669M21 MRR7977 002003-0313-15 47413 00000299516MR5 MR259430MR7 00000180851MR8 93908-1 0000000000Z028 5543 00000261679MR5 2565014 00000206586MR0 60357 00000000803M27 1306777 00000210768MR8 74954 00001301FMM049 MRHM0649 00000015524GQ2 2740638 00000000485M23 2839886 00000001141M21 1337081 00000169979MR2 79739-1 00000014934GQ4 2626380 00000290005MR8 2761824 00000173763MR4 2685572 00000296628MR1 2871647 00000005838M28 MRR9800 00000006147M23 1347499 00000106096MR1 1058 00000440437YM2 83306 00000002800GQ1 93827 00000001136M21 2834711 00000002891M20 MRR8616 00000014937GQ7 2682089 00000001608M29 MR280580MR2 00000004120M22 MRR9091 00000004249M29 MRR9132 00000154896MR5 42881 00000280084MR5 2651956 00000291191YM5 97920 00000002286M23 MRR8318 00000128415MR7 7366 00000156832MR8 1199233XXX 00000309476HM0 MRR8679 00000305303HM0 MRR8632 00000013877YR6 1337174 00000309092MR5 MRUA0272 000000000R7208 2812898 00000003289M26 MRR8738 00000002092M25 MRR8186 00000004323M22 MRR9153 00000003199M27 MRR8685 00000180497MR0 BR9313-1 00000282404HM3 MRR8213 00000299960MR5 MRR8022 00000000980M23 2745752 00000005112M28 MR1128SX8 00000346710YM7 37338-1 00000173706MR3 2668624 00000135761MR5 39016-1 00000010256GQ6 2570219 00000165928MR3 MR109698WH1 00000291193YM1 96328 00000003155M29 MRR8701 00000014325GQ5 2658698 00000015206GQ6 2679752 00000169512MR1 2686099 00000003308M24 MRR8755 00000014908GQ8 2681079 00000002269M29 MRR8291 00000000436M26 2836021 000000000R1854 MRR1854 00000308742MR6 MREU150557A 00001309FMM072 MRUA0191 00000005964M22 MRR9826A 00000003953M27 MRR9033 00000002639M23 MRR8461 00000217106MR4 2713328 00000003822M24 MRR8969 00000015636GQ4 2707330 00000269482MR6 47924-1 00000334277HM1 MRR9231 00000004927M20 MRR9475 00000013876YR8 MRR7614 00000263664MR5 2543512 00000014893GQ2 2643420 00000278843MR8 2644266 00000015811GQ3 2749156 00000309503HM1 MRR8714 00000321174HM5 MRR8972 00000006217M24 MRR9920 00000014328GQ9 2655256 00000015064GQ9 2682131 00000291138YM6 1093-1 00000317581HM7 MRR8881 00000000473M29 2839900 000000000R7192 2806189 00000301849MR6 MRR5100 000000HDMR1115 MRR7870 00000014418GQ8 2657932 00000004117M28 MRSXMR00001 00000001209M26 MR236696MR1 00000015208GQ2 2708867 00000151928MR9 2689428 00000HDMR10943 2690600 00000284717MR6 MRR5824 00001003BD6434 2869229 00000001164M23 2881401 00000001246M28 MRR7782 00000014553GQ2 1202514 00000219346MR4 8962 00000005829M27 MRR1560SX2 00000013649GQ9 2646955 00000015656GQ2 2803428 00000301209MR3 MRR3616 00000000720M23 2865321 00000005556M26 MRR8424 00000213060MR7 55611 00001048XF5027 MRHM0177 00000013860GQ2 2631480 00000300474MR4 MRHM0208 00000008327YR9 2871974-1 00000010475GQ2 MRR2782 00000166258MR4 2769055 00000015839GQ4 2742120 00000117765YM8 0785 00000006083M20 MRR9879 00000004060M20 MRR9131 00000005310M28 MRR9587 00000117764YM1 0788-1 00000307364HM0 MRR8647 000000000R7938 MRR7938 00000015966GQ5 2767032 00000117734YM4 270606 00000003963M26 MRR9140 00000299562MR9 MRR8093 00000005205M20 MR1263SX3X 00000439289YM0 8 00000005144M21 MRR9539 00000014369GQ3 2613126 000000HDMR6091 2723694 00000190316MR0 1167491 00000176673MR2 270682 00000190314MR5 2730951 00000214719MR7 2810285 00000016189GQ3 2771281 00000214722MR1 41986 00000291406MR7 1292548 000000000R6608 MRR6608 00000180404MR6 1185787 00000177056MR9 18918 00000014114GQ3 1196005 00000010974GQ4 MRR2396 00000005096M23 MRR9484 000000HDMR6308 2729019 00000175299MR7 1121870 00000010223GQ6 1185783 00001301FMM03E MRUA0122 00000126176MR7 23608XXXX 00000013558GQ2 1196362 00000325315YM0 1166 00001301FMM03L MR307144MR6 00000343991HM6 MRR9417 00000003137M27 1249807 00000010359GQ8 1111582 00000015204GQ1 2711191 0000097-0714-9 37542 00000015977GQ2 2767673 00000006377GQ6 2796256 00000203879MR2 1200954 00000016044GQ0 2723674 00000003805M29 MRR8992 00000004981M27 MRR9450 00000016131GQ5 2758029 00000186630MR0 2807598 00000678440YM9 11 00000015498GQ9 2730495 00000002339M20 MRR8325 00000003553M25 MRR8878 00000000620M25 2831309 00000010354GQ9 2809956 00000193340MR7 56597 00000001439M29 2900429 00000317032HM1 MRR9271 00000298518HM2 MRR8609 00000007359GQ3 2745813 00000015169GQ6 2718385 00000003095M27 2812884 00000293031MR1 2803426 00000174489MR5 2789864 000000000R3140 MRR3140 00000270672MR9 63336 00001204FMM04J MRHM0350A 00000299495MR2 MRWB0540 00000298382MR3 MRR6664 00000005228M22 90283 00000118969MR5 98128 00000015443GQ5 2718508 00000002341M26 MRR8322 00000140839MR2 2882660 00000290547MR9 2744677-1 00000002047M29 MRR8267 00000015566GQ3 2730882 00000166797MR1 88798-1 000000000R1050 MRR1050 00000170210MR9 76460 00000440384YM6 11998-1 00000287619MR1 2728519 00000288774MR3 2741697 00000002076M28 MRR8257 00000013854GQ5 2631482 00000000549M26 2834124 00000015916GQ0 2729403 00000015148GQ0 2691394 00001106XF5017 MRHM0342 00000219806MR7 34574 00000002327M25 MRR8313 00000293009MR7 2776720 00000002948M28 MRR8602 00000012864GQ5 MR255906MR0 00000016235GQ4 2776713 000000HDMR5803 2774902 00000135096MR6 29190 00000006376M28 MRR9968 00000005216M27 MRR9542 00000001634M25 MRR8049 00000000622M21 2807634 00000304438MR5 MRHM0448 0000009737-003 8094-1 00000440422YM4 12 00000308189MR0 1111407-2 00000266158MR5 13754 00000002570M20 MRR8432 00000011144GQ3 2541440 000000000R7983 MRR7983 00000005309M20 MR1461SX3 00000003395M21 MRR8789 00000218730MR0 43708 00000002468M27 MRR8392 00000002265M27 MRR8286 00000014460GQ0 1218275-1 00000000383M20 2806880 00000003528M27 MRR8835 00000010360GQ6 2527377 00000002099M20 MRR8194 00000001730M21 MRR2840 00000164788MR2 2599138 00000015541GQ6 2713415 00000296201MR7 2869224 00000002204M26 MRR8057A 000000000R3145 MRR3145 00000002528M28 MRR8415 002004-0617-18 2535122 00000303045MR9 2793555 00000266345MR8 1159312 00000005093M20 MR1235SX1 00000015444GQ3 2740829 00000270973MR1 1344119 000009948-0163 7318 00000002330M29 MRR8310 00000011885GQ1 MRR1683 00001301FMM048 MRUA0184 00000192239MR2 26290-1 00000301230MR9 MRHM0228 00000273039MR8 37684 00000003477M27 MRR8831 00000015651GQ3 2730904 00000270972MR3 75763 00000012621GQ9 1176346 00000169183MR1 45463 00001233FMM079 MRHM0523 00000308755MR8 MRHM0937 00000289113HM3 MRR8405 00000014533GQ4 1202525 00000291188YM1 94939 0000000000R470 2817679 00000298473MR0 2884624 00000013992GQ3 1191369 0000000000R559 2833969 00000201548MR5 36646 00000301917MR1 MRR8302 00000014456GQ8 2642447 00000280090MR2 2651831 00000014059GQ0 1202515 00000179915MR4 2731469 00000000573M26 2817431 00000156438MR4 975 00000297156MR2 2879385 00000005786M29 MRR9764 00000107167MR9 1090 00000001443M21 MRR7854 00000014497GQ2 2670666 00000000539M27 2831204 00000012444GQ6 1167250 00000015283GQ5 2719171 00000274172MR6 1186795 00000013788GQ5 2631456 00001308FMM03M MRHM0897 00000271786MR6 1111395 00000305132HM3 MRR8605 00000005730M27 MRR9749 00000003160M29 MRR8615 00000013511GQ1 2626827 00000014867GQ6 2664442 00000012111GQ1 2584646 00000001052M20 MRR7674 00000210675MR5 22951-1 00000069436HM4 13275 00000073845HM0 2513078 00000074727HM9 2513080 00000077329HM1 2527616 00000077917HM3 2515895 00000087383HM6 2538477-1 00000095606HM0 2551475 00000096361HM1 2540235 00000113839HM5 1164496 00000116729HM5 2589056 00000121731HM4 2594068-2 00000122119MH1 1177835-1 00000122120HM9 2626475 00000122122HM5 1176353 00000125858HM1 2603836 00000132998HM6 26370962 00000132999HM4 2619606 00000135974HM4 2645098XXXX 00000140388HM0 1171505-1 00000141635HM3 2622321 00000142460HM5 2640939 00000146237HM3 2621235 00000151304HM3 2601018 00000151789HM5 2631702 00000152457HM8 2633741 00000162551HM6 2684576 00000162758HM7 2680715-1 00000163981HM4 2680711-1 00000164854HM2 2680705-1 00000167489HM4 2675275-1 00000170639HM9 1235796 00000170953HM4 2713384 00000173915HM0 1233700 00000174559HM5 2689515 00000179351HM2 2713364 00000184911HM6 2686900-1 00000187941HM0 2731785 00000192703HM7 2745744 00000193896HM8 2749560 00000196632HM4 1285194 00000199904HM4 2713347 00000213017HM7 2761614 00000230348HM5 2821056 00000233945HM5 1320942 00000238234HM9 2852386 00000238600HM1 2852387 00000244339HM8 1346788 00000252931HM1 1347238 00000263620HM7 MR263615HM7 00000266430MR8 1193572 00000266954HM7 MR266959HM6 00000268116HM1 MR268111HM2 00000274242HM7 MR274237HM7 00000274893HM7 MR327566YM6 00000413122YM3 4325-1 00000157798HMO 2621425 00000004243M22 BG4571MR01 00000001028M20 BG4608MR01 00000004949M24 BG4609MR01 00000205013MR6 BG4029MR01 000000000R3618 BG4641MR01 00000015455GQ9 BG4538MR01 00000004498M22 BG4655MR01 104320 BG4568MR01 403777MR1 AM12F2I222 403777MR2 403925MR450B 780532MR1 306344MR1 604434MR 604941MR1 AM12O9T294 AM12O9T240 250492MOBMR 250717MR 604557MR1 604520MR2 604520MR1 604988MRI 604582MR450 604709MR 604822MRTS 604822CRY 604875MR750 604682MRI 604682MRI2 250727MRTS 604531MR 204787MRTS 506544MR1 506739MR1 506623MR1 506857MR2 506862MR2 506862MR1 506648MR2 506648MR4 506648MR3 709737MRI 902496MRI3 902473MR2 902567CRY 902893MR1 416249MR2 416249MR 905372MR 519824MR 905522MR2 905521ONI 905527MR1 613632MR1 519569MR 519685CRY3T 519663MRC 519663MRI 519685MR1 905731MR 905895MR1 613721MR1 613562MR1 613737MR1 416744MR 416340MR2 416486MR2 416212MR450 416813MR3 416369MR3T 416369MR2 416369MR3 519767MR1 819732MRI 819762MRI 514262MR1 819420MRI 450668MR1 450688MR 450670MRI 450670MR2 514281MR450 514495MR 514934MR1 514341MRI 514848MR1 514331MRI 514697ONI 418723MRI 819822MR1 450778MRI 514759BMRI 418682BMR1 819825MRI 514765MRI 306766MR3 306766MR2 00000011758GQ0 412099MR1 00000299538MR9 ILSMR1 00000014804GQ9 MMAIPUMR1 00000013737GQ2 PASSMR1 00000300573MR3 OESTEMR1 00000001285M26 CBSMR1 00000206582MR9 562225MR2 00000299621MR3 MRR7323 00000216613MR0 22106MR1 00000175296MR3 INTAMR01-1 00000003817M24 MRR4116 00000005337GQ1 23954MR1 00000005477M25 MRR5840 00001009BD659E CLCMR1 00000303379MR2 HBLUCOMR01 00000003474M24 MRR8844 00000261206MR7 CATMR01 00000340776HM4 MRR9350 00000003978M24 MRR9031 00000012270GQ5 HVBMR01 00000272432MR6 CRMR01 00000000530M26 HCVMMR1 00000016056GQ4 MEDSMR2 00000003522M20 MRR8837 00000005059M21 082427190067 00000004217M26 082427300017 00000214507MR6 082427110010 00000003403M23 082427020040 00000001827M25 082427070072 00000937BD5ED9 082427110026 00000003762M22 082427090191 00000294570MR7 082427090175 00000014374GQ3 082427090071 00000003527M29 082427020043 00000016256GQ0 082427170006 00000301104MR6 082427170011 00000294141HM7 082427210067 00000003332M24 082427210094 00000003335M27 082427110039 00000292549MR3 082427120062 00000011877GQ8 082427120052 00000300953MR7 082427310034 00000005741M24 082427310069 00000003791M21 082427310050 00000001592M25 082427310036 00000003118M27 082427190053 00000002392M29 082427280006 00000003307M26 082427280007 00000003773M29 082427060041 00001106XF507B 082427060042 00000003024M27 082427320001 00000291137MR8 082427060026 00000001247M26 082427090136 00000015345GQ2 082427190034 00000299265MR9 082427160070 00000003610M23 082427150050 00000003778M28 082427160099 00000305144HM8 082427160092 00000012007GQ1 082427160043 00000001680M28 082427160079 00000277189MR7 082427160049 00000002381M22 082427170013 00000015880GQ8 082427190036 00000217110MR6 082427190006 00000003776M22 082427140069 00000000577M27 082427250019 00000306734MR5 082427140094 00000000981M21 082427140056 002004-0805-02 082427090035 00000003763M20 082427090189 00000002317M26 082427090154 00000279802MR3 082427140041 00000012484GQ2 082427140035 00000000745M20 082427150035 00000016165GQ3 082427090106 00000011028GQ8 082427160037 00000001875M24 082427160082 00000005639M20 082427270047 00000003784M26 082427170017 00000001222M29 082427190045 00000012567GQ4 082427120038 00000003304M23 082427090168 00000001244M23 082427190044 00000000705M24 082427100118 00000006288M25 082427150067 00000002132M29 082427100142 00000003201M21 082427160095 00000001923M22 082427250025 00000014903GQ9 082427090072 00000005810M27 082427090220 00000002080M20 082427090149 00000003380M23 082427030069 00000003422M23 082427030070 00000321168HM7 082427070084 00000003759M28 082427210099 00000005708M23 082427210120 00000005267M20 082427210122 00000002219M24 082427210071 00000005910M25 082427240045 00000000957M21 082427230043 00000003820M28 082427240028 00000282501MR6 082427070049 00000002870M24 082427100163 00000003502M22 082427100175 00000004831M24 082427160104 00000286800MR8 082427100089 00000439294YM0 082427100017 00000950BD62B5 082427100119 00000004611M20 082427160107 00000016138GQ0 082427160062 00000270384MR1 082427030029 00000015725GQ5 082427070052 00000005833M29 082427070110 00000003394M24 082427010055 00000005464M23 082427070113 00000001208M28 082427070067 00000321877HM3 082427070082 00000004787M28 082427210110 00000914BD5A82 082427070062 00000003645M29 082427010057 00000014802YR3 082427070074 00001106XF50DD 082427210081 00000003347M22 082427210097 00000001366M24 082427210062 00000002404M22 082427210080 00000004316M26 082427070093 00000005151M26 082427140072 00000003828M21 082427140089 00000007680GQ2 082427140021 00000000702M21 082427060030 00000000958M29 082427060033 00000003330M28 082427060039 00000002377M20 082427060035 00000004847M20 082427090183 00000307351HM7 082427090153 00000006443M26 082427090233 00000010646GQ8 082427090060 00000011186GQ4 082427090181 00000001990M21 082427090147 00000272336MR9 082427030031 00000000281M26 082427100113 00000002407M25 082427100145 00000005705M29 082427140093 00000002914M20 082427140079 00000012034GQ5 082427100187 00000006110M21 082427100224 00000004972M26 082427160112 00000005733M21 082427160122 00000002836M25 082427100162 00000000997M27 082427160073 00000002316M28 082427010049 00000004122M28 082427010066 00000005729M29 082427120127 00000014764GQ5 082427120054 00000004048M25 082427120103 00000004814M20 082427120111 00000002087M25 082427120084 00000000258M24 082427120065 00001302FMM057 082427120101 00000004816M25 082427120114 00000006090M25 082427200065 00000005644M20 082427200070 00000373559HM4 082427200067 00000001318M25 082427180021 00000000596M27 082427100116 00000015507GQ7 082427100094 00000004729M20 082427210079 00000003296M21 082427140081 00000004931M22 082427070105 00000004557M25 082427090209 00000005123M25 082427090216 00000003246M26 082427010058 00000004973M24 082427070118 00000005270M24 082427090222 00000001777M22 082427240015 00000001991M29 082427240016 00000002411M27 082427240017 00000005877M26 082427240042 00000003646M27 082427110038 00000003685M25 082427230060 00000004127M27 082427230063 00000002436M24 082427110032 002004-0128-07 082427230013 00000002290M25 082427110033 00000005449M24 082427070121 00000002539M25 082427310041 00000001830M29 082427200040 00000000789M28 082427180018 00000016262GQ8 082427110023 00000001799M26 082427200037 00000004195M24 082427210101 00000005704M22 082427080043 00000001064M25 082427210061 00000006316M24 082427310075 00000002322M26 082427310043 00000306731MR1 082427310057 00000279423MR8 082427310015 00000003818M22 082427310053 00000003300M21 082427210096 00000003772M21 082427210089 00000373574HM3 082427070085 00000000698M21 082427070064 00000002691M24 082427070077 00000016063GQ0 082427210046 00000002590M28 082427210085 00000003932M21 082427270036 00000015682GQ8 082427140048 00000004491M27 082427030077 00000002850M26 082427150046 00000001204M27 082427140060 00000004046M29 082427140088 00000002702M29 082427270034 00000355601HM6 082427270041 00000000823M25 082427030053 00000004108M27 082427140090 00000015152GQ2 082427230083 00000004099M28 082427020045 00000003714M23 082427030075 00000016243GQ8 082427030043 00000004338M20 082427030079 00000282686MR5 082427010032 00000003710M21 082427020044 00000003317M25 082427020046 00000002645M20 082427270033 00000003165M28 082427270035 00000011633GQ5 082427140037 00000004922M21 082427140100 00000001484M25 082427010046 00000300483MR5 082427010047 00000004776M21 082427120112 00000338045HM8 082427120108 00000004121M20 082427010070 00000003386M20 082427150049 00000002154M23 082427150039 000000000R1897 GEMRC09004-1 00000117729YM4 GS27170001 00000004119GQ4 GS27100018 00000002293M29 082427020033 00000005450M22 082427060050 00000006098M28 082427010083 00000006314M29 082427010088 00000000853M22 082427010043 00000005268M28 082427010076 00000005651M25 082427010078 00000005781M20 082427060053 00000005513M27 082427060054 00001106XF5105 082427260003 00000000701M23 082427020029 00000003329M20 082427190054 00000003006M24 082427090188 00001302FMM044 082427150058 00000014981GQ5 082427150029 00000010704GQ5 082427150031 00000011266GQ4 082427250012 00000005963M24 082427250040 00000004419M28 082427020048 00000000090M21 082427190041 00000003684M28 082427090177 00000000748M24 082427090128 00000005562M24 082427250036 00000006445M21 082427020054 00000003293M28 082427090158 00000003807M25 082427090197 00000003827M23 082427090185 00000000761M27 082427090121 00000010689GQ8 082427150018 00000015355GQ1 082427170005 00000001291M24 082427170009 00000000581M29 082427020028 00000014670GQ4 082427150028 00000277487MR5 082427150027 00000001040M25 082427150036 00000002704M25 082427150044 00000002862M21 082427150043 00000005354M26 082427090225 00000015746YR1 082427090176 00000001807M27 082427090138 00000282790MR5 082427090083 00000000203M20 082427090111 00000015094GQ6 082427230029 00000003196M23 082427190052 00000004746M24 082427190060 00000439286YM6 082427090015 00000016091GQ1 082427090094 00000002555M21 082427090155 00000002721M29 082427090152 00000002581M27 082427090162 00000003401M27 082427090178 00000002563M25 082427090145 00000320073HM0 082427090186 00000004921M23 082427090217 00000004540M21 082427100193 00000002834M20 082427100157 00000001305M22 082427100125 00000005707M25 082427200079 00000013055YR9 082427060027 00000169178MR1 0930042246 00000948BD61E4 082427010038 00000001781M24 082427160077 00000300952MR9 082427160081 00000015662GQ0 082427010035 00000014411GQ3 082427010031 00000001364M29 082427160075 00000003188M20 082427100165 00000293715MR9 082427100124 00000004101M22 082427100189 00000006020M22 082427100221 00000014954GQ2 082427100092 00000288811MR3 082427100099 00000005820GQ6 082427100024 00000002292M21 082427100150 00000002799GQ5 082427100081 00000001280M27 082427160074 00000002751M26 082427100167 00001307FMM04C 082427200058 00000001750M29 082427200038 00000003679M28 082427200051 00000015162GQ1 082427200022 00000000890M24 082427120073 00000294526MR9 082427120076 00000004310M29 082427180024 00000003815M28 082427200055 00000005779M24 082427200071 00000004774M26 082427200059 00001307FMM08G 082427160118 00000003010M26 082427160080 00000005618M24 082427160106 00000001872M21 082427160083 00001245FMM03L 082427010072 00000012116GQ0 082427120035 00000004843M29 082427200061 00000010673GQ2 082427100047 00000006411M23 082427160130 000000HDMR5478 082427120060 00000003701M20 082427120094 00000015467GQ4 082427030041 00000302534MR3 082427310046 00000005398M23 082427250034 00000002923M21 082427250031 00000004090M27 082427270038 00000439309YM6 082427270008 00000003026M22 082427310044 00000015889GQ9 082427100104 00000001939M28 082427030061 00000000380M26 082427090112 00000919BD5BC2 082427070054 000000000R7508 GEHANGWEI 002003-1210-16 082427040038 000000HDMR5757 082427040092 0002005-0914-1 082427040053 00000308162MR7 082427040137 00000000361M26 082427040095 00001307FMM07W 082427040154 00000000768M22 082427040104 00000287879MR1 082427040076 00000015991GQ3 082427040083 00000011374GQ6 082427040070 00000000179M22 082427040093 00000279159MR8 082427040072 00000937BD5EE0 082427040098 00001318FMM006 082427040161 00000005586M23 082427040156 00000293676MR3 082427040106 00000306732MR9 082427040133 00000292090MR8 082427040088 00000301928MR8 082427040113 00000267977MR7 082427040054 00000005814M29 082427040159 00000001408M24 082427040112 00000013807GQ3 082427040067 00001302FMM04F 082427040148 00000006205M29 082427040162 00001201FMM089 082427040153 00000301753MR0 082427040121 00001046XF5006 082427040105 00000002805M20 082427040129 00001302FMM04A 082427040114 00000000859M29 082427040102 00000267037MR0 082427040066 00000257452MR3 082427040029 00001003BD6404 082427040100 00001008BD653D 082427040099 00000264741MR0 082427040050 00001302FMM04M 082427040141 00000289004MR4 082427040074 00000002287M21 082427040122 00001011BD6645 082427040110 00001011BD6685 082427040109 00001018XF5019 082427040119 00000002465M23 082427040125 00000016124GQ0 082427040086 00000261200MR0 082427040044 00000262931MR9 082427040047 00000280302MR1 082427040085 00000002970M22 082427040115 0000000UA0199A 082427040146 00001106XF5073 082427040120 00000HDMR10281 082427040073 00000265179MR2 082427040051 002003-1211-25 082427040037 00001012BD66CC 082427040101 00001106XF5043 082427040127 00000013272GQ0 082427040065 00000000737M27 082427040103 00000GE0206027 082427040020 00000015348GQ6 082427040089 00000000684M21 082427040097 00000271126MR5 082427040058 00000307111MR5 082427040142 00000271233MR9 082427040046 00001101XF5016 082427040123 00000002447M21 082427040124 002004-0713-19 082427040041 00000267204HM6 082427040126 00001106XF5055 082427040116 00000393816YM4 082427040012 00000308180HM9 082427040131 00000005732M23 082427040158 00001106XF50DF 082427040132 000000HDMR5530 082427040080 00000188456MR8 082427040013 002002-1015-33 082427040024 00000001733M25 082427040096 00000266147MR8 082427040061 00000212572MR2 082427110009 00001009BD6575 082427030057 00000272893MR9 082427100065 00000003992M25 082427100191 00000001589M21 082427140064 00001101XF5035 082427070075 00000279751MR2 082427070046 002005-1201-15 082427020017 00001307FMM07V 082427020056 00000912BD59A3 082427020027 00000003792M29 082427190056 00000196172MR1 082427190004 00000300770MR5 082427270032 00000938BD5F17 082427190069 00000336977HM4 082427190058 00000224150MR3 082427190007 00000003203M27 082427190055 002002-0422-14 082427190011 00000014933GQ6 082427190035 00000002525M24 082427190050 00000010495GQ0 082427120032 00000002742M25 082427230054 00000257756MR7 082427230015 00000003303M25 082427230040 00000012001GQ4 082427230017 00000000736M29 082427230037 00000003936M22 082427230061 00000003686M23 082427230062 00000005791M29 082427230080 00000000716M21 082427230039 00000000063M28 082427190038 00000000109M29 082427190037 00000005950M21 082427190077 00000002863M29 082427110035 00000015396GQ5 082427230031 00000004045M21 082427220027 00000003659M20 082427220029 000000HDMR5783 082427220016 00000000918M23 082427220022 00000003139M23 082427220026 00000002420M28 082427220023 00000004062M26 082427220031 00000004040M22 082427220032 00000002957M29 082427220028 00000002650M20 082427220024 00000004245M27 082427220030 00000914BD5A77 082427220018 00000005233M22 082427220033 00000267650MR0 082427220010 00000919BD5BA1 082427220020 00000919BD5BB7 082427220019 00000014534GQ2 082427220013 00000009527GQ3 082427220036 002004-1130-03 082427030026 00000000358M22 082427030047 00000009219GQ7 082427030020 00000002523M29 082427030066 00000003652M25 082427170015 0000000000R700 082427010008A 00000008655GQ3 082427010021 00000004058M24 082427150052 00000005734M29 082427210126 00000003320M29 082427010059 00000004723M23 082427230071 00000004251M25 082427150057 00000289798MR1 082427100093 00000014120GQ0 082427100072 00000353136HM5 082427160116 00000275091MR7 082427160046 00000004113M27 082427200057 002003-0611-02 082427140018 00000005203M25 082427100210 00000002201GQ2 082427100016B 00000003287M20 082427210093 00000013855GQ2 082427210036 00000000883M29 082427090122 002004-0729-08 082427150022 002004-0528-15 082427150040 00000421235YM3 082427200001 002004-0528-18 082427150019 00000296468MR2 082427200039 00000009328GQ6 082427200012 00000001036M23 082427120074 00000015841GQ0 082427100100 00000006312M23 082427250039 00000002163M24 082427100139 00000015606GQ7 082427160057 00000276370MR4 082427160052 00000279752MR0 082427160050 00000848BD5311 082427160065 002004-1102-18 082427160031 00001302FMM04U 082427160101 00000010986GQ8 082427160036 000000000R2810 082427160021 00000292027MR0 082427160064 00000000204M28 082427160067 00000015601GQ8 082427160055 00000016099GQ4 082427160063 00001105XF502F 082427160088 00000000459M28 082427180016 00000003877M28 082427240026 00000265632MR0 082427240009 00000003782M20 082427140086 00000004111M21 082427030073 00000003521M22 082427280010 00000003808M23 082427160097 00000002744M21 082427170014 00000001536M22 082427170007 00001106XF508E 082427070079 00000002413M23 082427140073 00000192241MR8 082427140010 00000283174MR1 082427140047 00000299192MR5 082427140062 000000HDMR6035 082427140054 00000000974M26 082427140055 00000272894MR7 082427140039 00000439302YM1 082427010020 00000001935M26 082427070073 00000000368M21 082427070060 00000001331M28 082427110029 00000905BD5673 082427110025 00000153415MR5 082427110001 00000015807GQ1 082427010037 00000002960M23 082427090167 00000005456M29 082427090236 00000014417GQ0 082427100154 00000003433M20 082427100183 00000000590M20 082427120069 00000011057GQ7 082427190026 00000836BD4DB3 082427110024 00000206580MR3 082427110008 00000169370YM4 082427110003 00000005271M22 082427210118 00000002688M20 082427100159 00000299191MR7 082427060032 00001308FMM047 082427060052 00000170908MR8 082427060008 00000002113M29 082427200041 00000004916M23 082427200054 00000004779M25 082427190065 00000277583MR1 082427140040 00000299539MR7 082427140077 00001002BD6360 082427010041 00000002932M22 082427010053 00000307370HM7 082427210092 00000002342M24 082427120075 00000005641M26 082427160121 00000004952M28 082427160120 0002005-1201-2 082427120041 00000302474MR2 082427120089 00000001882M20 082427230045 00000005475M29 082427210119 00000012582YR3 082427250021 00000000363M22 082427080024 00000004449M25 082427230064 00000000569M24 082427100114 00000001277M23 082427090135 00000208227MR9 082427090012 00000005042M27 082427100206 00000015376GQ7 082427140049 00000005564M20 082427210117 00000301773MR8 082427160094 00000281704

Other Recalls from GE Healthcare

Recall # Classification Product Date
Z-1475-2026 Class II GE Healthcare Centricity Universal Viewer Zero ... Jan 16, 2026
Z-1487-2025 Class II GE Healthcare Centricity Centricity PACS-IW wit... Feb 19, 2025
Z-1484-2025 Class II GE Healthcare Centricity PACS-IW (PACS-IW), Mod... Feb 19, 2025
Z-1486-2025 Class II GE Healthcare Centricity Cardiology CA1000 (CA1... Feb 19, 2025
Z-1485-2025 Class II GE Healthcare Centricity Radiology RA600 (RA600... Feb 19, 2025

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from GE Healthcare Recalls by Firm Recall Reasons Device Safety Stats