GE Healthcare…

Date

April 1, 2015

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

Terminated

Filed by

GE Healthcare

Product

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

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.

Quantity

9,369 (2,937 US, 6,432 OUS).

Codes and lots

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…

Recall started

March 9, 2015

Device type

System, Nuclear Magnetic Resonance Imaging

Root cause (FDA)

Software Manufacturing/Software Deployment

What the company told customers

GE Healthcare sent an "Urgent Medical Device Correction" letter dated March 9, 2015, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact your local service representative or call 800-437-1171 (available 24 hours a day).

Recall number

Z-1305-2015

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

Source: FDA · Medical device enforcement report, recall number Z-1305-2015. The agency record governs; check it and the company before acting.