This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450…

Date

Feb. 25, 2015

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Terminated

Filed by

GE Healthcare

Product

This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.

Reason

At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.

Distribution pattern

Worldwide Distribution - US Nationwide in all states in continental USA including DC, PR, GU, and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR,K ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE , UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, ZAMBIA.

Quantity

12,968 (5,708 US, 7,260 OUS).

Codes and lots

Mfg Lot or Serial # System ID 00000678440YM9 11 00000439289YM0 8 00000440422YM4 12 00000159739MR2 10 00000340776HM4 MRR9350 00000300911HM5 MRR8614XXX 00000307145MR3 MR307145MR3XXX 00000347253HM7 MRR9546XXX 00000014401YR4 2867718MRHDEXXX 00000227450MR7 333MR3TXXX 00000286146MR6 813EXCITEHDXXX 00000005670GQ5 33575MRI 00000015190GQ2 813EXCITEHD 000000000R5168 PPR88300 00000263679HM3 MEX68913 104203 GPX23300 00000117703YM9 MP917500 00000275290MR5 M2322231 00000144994MR1 F4168003 00000142868MR9 M9886807 00000208223MR8 M4488929 00000834BD4B76 M2865810 00000015769GQ3 M200598201 00000287360MR2 IL1028MR04 00000269936MR1 110010MR03 00000010081GQ8 M4497252 00000265724MR5 80040MRS02 00000213821MR2 00568MRS02 00000274388MR8 M4160077 00000439293YM2 850270280 00000439303YM9 850270057 00000439318YM7 850270174 00000439320YM3 850270022 00000439325YM2 850270186 00000279611MR8 10079MRM74 00000000905M20 PL2130MR01 00000165934MR1 850270060 000000000R6047 55MR2726459 00000284297MR9 83027062101067 00000264745MR1 83027602200145 00000265178MR4 83027202100215 00000270025MR0 83027242101006 00000273677MR5 83027862100276 00000274832MR5 83027202100306 00000286281MR1 83027602101557 00000276493MR4 BA4073MR01 8.70972E+21 706774MRI 412648MR1 412784MR1 317630HDMR 610902HD1 MSK55MR1 317630MR1 LONGWOOD15MR 330535MR2 859226MR 208367LX12 00000014890G08 910272052 00000264618MR0 M4016036 00000015059GQ9 SA1014MR02 00000264740MR2 AZ1003MR01 00000262798MR2 KW1013MR02 00000274935MR6 SY2037MR01 352344MR ALLIANCESIG437 409838HDCMR1 INSIGHTMR2025 954587MR1 210590NEHDMR 940220MR1 00000015200GQ9 SD1063MR01 00000276248MR2 27003MRS01 00000013471GQ8 856270037 00000013391GQ8 24527633818MRI 00000290734MR3 2771768 00000014972GQ4 A5395304 00000282503MR2 LV4038MR01 00000267807MR6 DZ1057MR01 00000273006MR7 2624537EXCITE 00000014505GQ2 IR1288MR02 00000013604GQ4 KW1018MR01 00000272427MR6 SI4024MR01 00000276153MR4 3882676145MRMET 00000280627MR1 3882676151MRCTR AM11ZVXTLW7 210351HDMR 708747OFMR 412641MR2 360487MR2 8.70972E+13 609395MR 518347MR SUTTERLSMR 804270HDMR 804CHESMR 702731MR3 407CDIMR 412856MR 469461BNPMR1 205877MR3 936568HDX 209SUTAMDMR 330363MR 973661MR 740588MR 916KMMR 732548MR 973754MR 606833MR 770844NFMR 530WOODMR 502955JSMR 512795HDMR 859263MR ALLIANCESIG429 805PIMR1 303837MRI 508746JMR2 352WATOUT 432520MR 719524MR 760323MR 830643MMR2 937558MR 805LRMR1 317582MR1 513870MR 916KEGMR 716859MR1 716878MR1 252209RCMR 386FHDMR 252OBXMR 330334MR 407CFRMR 920451ASMHD1 615451MR1 818409MR1 317865CWHMR 806GRACEMR 812485MR2 812537MR 775RENT1 972487BGMR2 972875LPMR1 330945MR 407303FEMR2 804BSIMR 540994MR 323441MR2 323441MR3 512528CPMR1 918461HD 908555MR 281364HDMR 210681MSWHMR 614898MR2 512341RRMR2 480323MR2 951276MR 615451MRHD 801479MR1 818843SJMR1 915685MR 503370MR1 617732MR4 319768GRHSMR1 651232WMR1 530756MR 816969MR 318388MR 413447MR2 804594SFMR 713662UTIMR 308534MR 360486SPMR WH231MR1 409938MR1 404278HMR2 972617REDMR1 773884HCMR 858626MR2 212420MR2 573785PBRMR 805681MR2 989583MRI 269556MR 360582MR2 651439MR1 214820BPMR2 480543MR1 281352MR1 509891MR 213202MR 760843MRI 310671MR 00000268421MR5 910274019 00000274172MR6 1186795 00000281257MR6 2662228 00000284643MR4 2705171 000000HDMR6308 2729019 00000175299MR7 1121870 00000013383GQ5 2621191 00000013558GQ2 1196362 00000014059GQ0 1202515 00000015204GQ1 2711191 00000261679MR5 2565014 00000264088MR6 2567724 00000264742MR9 2562525 00000269379MR4 2591063 00000269572MR4 1184373 00000279085MR5 1202478 00000282730MR1 A5228507 00000264094MR4 A5661503 00000268115MR3 A5232804 00000268117MR9 A5108718 00000273226MR1 A5650208 00000279454MR3 H5274803 00000261868MR4 60001MRS01 00000279083MR0 20001MRS02 00000270390MR8 10516MRS01 00000270626MR5 ZA1180MR01 00000014714GQ0 SA2051MR01 00000015014GQ4 SA1021MR01 00000282464MR7 SA1034MR02 00000269046MR9 847270017 00000269325MR7 F4168013 0000000000R566 DK1317MR01 00000274109MR8 A5106403 00000014965GQ8 3882691524MRCTR 00000266069MR4 A033MR01 00000015088GQ8 A5177224 00000272964MR8 C4194430 00000000989M24 PL1807MR01 00000001240M21 PL1030MR02 00000277191MR3 3882635801MRSOR 00000011758GQ0 412099MR1 00000012270GQ5 HVBMR01 609490MR 623583MR1 765473MR 812825MR1 507825MR 863686MR 478757MR 509536MR 713PMCMR1 00000261206MR7 CATMR01 00000272435MR9 83027002101846 626281HDMR 352401MR 307672MR 601815MR1 520381MR1 702616MR 928758MR 973MR LEOMINSTERMR1 402778OWMR1 513894MR 813634MR2 513247MR 541608MR 702382MR 717270MR1 205750MR04 941798MR 518782LMR2 401348MR1 561650MR2 949863MR1 803936MRI 606439HDMR 847BNJMR1 205822MR1 828757MRI 417256MR2 909581MR 317338MR4 219326MR 215728HD 212140MR2 931245MR1 269945MR 520202MR 609597MR1 561694MR3 406863WMR SUTTERDELTAMR 937278MR 704984SHD 518583MR 951677MR2 937439MR 804APMXMR 706651MR 256ALOPMR 972599VILMR1 845871MR 601485MR2 208265BMR 904399MR2 661PMCMR 480612MR1 518584SSMR 518782LMR 901226MR3 910343NHMR 520547MR 281KELSEYMR1 713442KSMR2 713799TMR3 765349MR1 607432MR 219736SLMR2 631686MR 276228MR 863RMCMR1 608364MR1 704355LCHMR 334347MR 281599MR 850325CMR1 805737MR 303794MR 303762MR 518483MR 806UMCHDMR 623234MR1 00000014328GQ9 2655256 00000014418GQ8 2657932 00000014497GQ2 2670666 00000015586GQ1 5338MR15T 516579MR1 405307NMR 405742SMR 614898MR 949721MR1 309655MRI1A 541382SCMR 858939MR2 817472MCAMR1 504447MR15 818713MR1 203325MR4 307578MR 614293MR7 603650HDX 301295HDX 214420MR1 503370MR2 828286RHMR 770533MR 605333MR1 901287MR1 360254NMR1 00000002891M20 MRR8616 00000003302M27 MRR8519 828324MR1 502587JMR1 828696MR 956698HDX 916MEGMR 404251EOMR 214820IMR1 509458DMR1 915569WMR 706378MR2 828696MR2 00000001172M26 PL1312MR01 00000279892MR4 06108MRS01 002002-0605-12 LY1006MR01 00000011085GQ8 KW1005MR02 3825 801377MR2 513369MRT 415353MRC1 3600 604682MRI 604822MRTS 00000265916MR7 DK1083MR03 00000269339MR8 FI1025MR01 386HPOMR 858822MR3 323441MR1 409892SMR2 619465GMR1 814234MR 910716BMR1 412537MR 713792AMR3 INSIGHTMR3072 303SKYMR 805988MR2 626821MR2 480323MR1 281SMCMR1 713456OPMR1 609383MR 916784MR2 00000265866MR4 2577595 418691MR 514842AMRI 00000263872MR4 A5605733 00000271659MR5 A5102656 00000272075MR3 A5125121 00000272079MR5 A5806911 00000266670MR9 SA1006MR02 00000287999MR7 PL1677MR01 00000012171GQ5 A5401507 00000297007MR7 850270329 00000298272MR6 850270337 00001106XF5004 850270385 00000266737MR6 920279017 00000015533GQ3 PL1650MR01 SMSAIL1 SMSHML2 AM12JPH43 AM129XM83 AM12EE91242 678474JCMR 00000004117M28 MRSXMR00001 00000002050M23 83027607456611 00000002434M29 83027009509112 00000003970M21 83027280035313 00000005225M28 83027805544513 00000005957M26 83027848755514 00000278675HM4 850270372 00000301932HM0 850270429 00000001405M20 850270349 00000001522M22 850270352 00000001665M29 850270356 00000001723M26 850270364 00000001983M26 850270374 00000002100M26 850270378 00000002335M28 850270383 00000002541M21 850270390 00000004966M28 850270433 00000004984M21 850270431 00000005794M23 850270434 00000005510M23 MRR9674 00000005404M29 MRR9629 00000293806HM6 AZ4010MR01 00000295711HM6 AZ4004MR01 00000308926HM5 AZ4015MR01 00000004957M27 AZ4030MR01 00000005154M20 AZ4027MR01 00000300905HM7 MRR8562 00000002570M20 MRR8432 00000004934M26 MR1109SX8 00000001028M20 BG4608MR01 00000003474M24 MRR8844 00000003235M29 EG1008MR02 00000003239M21 805609MR01 00000281416HM8 GH1043MR01 00000252375MM1 083027209313010 00000257792HM2 083027200046510 00000266900HM0 083027820034810 00000267201HM2 083027603806711 00000267643HM5 083027060039211 00000269309HM1 083027044291311 00000276180HM7 083027861104811 00000293130HM1 083027208469611 00000295723HM1 083027800405712 00000298515HM8 083027240046912 00000305147HM1 083027860004512 00000306415HM1 083027240006712 00000307327HM7 083027280009412 00000314752HM7 083027100019412 00000000802M29 83027206937710 00000000819M23 83027007207410 00000001087M26 83027601012510 00000001235M21 83027849928710 00000001284M29 83027849948410 00000001571M29 83027842855011 00000001603M20 83027841020511 00000002125M23 83027206189511 00000002433M21 83027868443311 00000002440M26 83027207969111 00000002504M29 83027860044912 00000002692M22 83027100049812 00000003014M28 83027000004112 00000002415M28 835270023 00000280905HM1 A5437701 00000001313M26 A5279817 00000002284M28 A5342909 00000002738M23 A5274202 00000001879M26 KA1187MR01 00000270510HM1 LV4004MR01 00000290024HM9 834270018 000000000R8614 MRR8614 00000256144HM7 MA1421MR01 00000257546HM2 MA1014MR02 00000004408M21 MA1085MR01 00000306421HM9 NG1097MR02 00000321165HM3 NG1116MR01 00000002414M21 NG1097MR01 00000002978M25 NG1127MR01 00000003770M25 NG1065MR01 00000001122M21 PL1809MR01 00000002346M25 RO1221MR01 00000289389HM8 RU3205MR02 00000290015HM7 RU2652MR02 00000317560HM1 RU3951MR01 00000001495M21 RU3759MR01 00000001645M21 RU3777MR01 00000001774M29 RU3776MR01 00000001893M27 RU3794MR01 00000001900M20 RU3788MR01 00000002162M26 RU2607MR01 00000002194M29 RU4687MR01 00000002195M26 RU6484MR01 00000002260M28 RU2272MR01 00000002298M28 RU1778MR01 00000002386M21 RU2652MR01 00000002626M20 RU3240MR01 00000003131M20 RU7404MR01 00000003498M23 RU1239MR01 00000003533M27 RU1997MR01 00000001520M26 SA1237MR01 00000001468M28 ZA1058MR01 00000004337M22 ZA2471MR01 00000002866M22 856270051 00000004187M21 856270056 00000268815HM8 55021MRS01 00000269415HM6 07027MRS01 00000284478HM5 06138MRS01 00000286883HM4 09015MRS01 00000305315HM4 54003MRS01 00000330654HM5 48005MRS01 00000001631M21 34334MRS01 00000002478M26 34340MRS01 00000003130M22 46014MRS01 00000004179M28 07023MRS02 00000004326M25 46016MRS01 00000004548M24 13007MRS01 00000295720HM7 UZ1020MR01 00000000747M26 83027607456310 00000002885M22 MA1479MR01 AM11ZM4HLH9 305592MR1 256TICMR1 731422MR1 813259MR 513250MR 4109068 4141506 4210916 4215690 440684MR 4217069 4225685 00000005809M29 DZ1598MR01 00000006310M27 MRR9946 00000004431M23 M24313803 00000004506M22 X669977012 00000005558M22 O9885031 00000005620M20 X751968029 00000005771M21 M353936501 00000006193M27 M359673901 00000006216M26 M9886861 00000006220M28 M196514406 00000006368M25 X185801209 00000006523M25 M369617701 00000006572M22 M1279748 00000006241M24 GE1157MR01 00000005082M23 174366MR01 00000005109M24 PC2034MR02 00000005113M26 835270040 00000005636M26 835270046 00000005913M29 B208415201 00000005988M21 MA1526MR01 00000005102M29 843270024 00000004868M26 RO1248MR01 00000005597M20 RO1259MR01 00000005402M23 RU7939MR01 00000005905M25 RU8658MR01 00000006132M25 RU8772MR01 00000006201M28 RU8755MR01 00000004418M20 22011MRS01 00000004718M23 33036MRS01 00000005122M27 34004MRS01 00000005148M22 07004MRS02 00000005588M29 63019MRS01 00000005649M29 63016MRS01 00000005793M25 34397MRS01 00000005919M26 06156MRS01 00000006192M29 33042MRS01 00000006502M29 43014MRS01 00000005104M25 AE1432MR01 00000005969M21 859270019 00000005118M25 PA1051MR01 00000275848MR0 910272001 909748MR LGMR151 662720MR1 904732MRLX 864582MR 360577MR1 952930MR1 503293MR1 559442FCMR2 205345MRI AM12F2I21 AM12A5T266 AM12DCX575 AM12EAV123 AM12C1X45 AM12CZM50 AM12JPH24 AM12I4P77 AM12NBX305 AM12NJV515 209577MRMR 205939MR2 ALLIANCESIG209 281588MR1 620231MMRI 925467MR 513936MR 209536SMR 843916MR 307674SOMR 813968MR 518713MR RADNETMR1510 410561MR2 514331MRI 00000193390MR2 AE1011MR01 00000309135MR2 PC2007MR01 00000219810MR9 ZA1105MR01 ALLIANCESIG451 00000015525GQ9 2711174 000000000R3801 424881MR01 00000306957MR2 PB1702MR01 00000308884MR6 PC7393MR01 00000219341MR5 ZA1059MR01 00000292433MR0 PC1961MR01 570271MR1 002001-0425-21 850270087 00000180038MR2 850270325 00000193971MR9 850270082 00000008646GQ2 GOLD010252 000000000R5536 GOLD010926 00000286145MR8 83027062101391 00000012163GQ2 856270036 00000265058MR8 856270035 00000014978GQ1 856270042 00000282958MR8 SA1041MR02 00000001753M23 856270046 00000014061GQ6 PL1649MR01 00000291331MR7 PL1505MR02 000000000R2581 850270128 000000000R4427 850270184 00000093647MR6 850270020 00000104683MR8 850270019 00000109626MR2 850270027 00000112344MR7 850270034 00000189377MR5 850270171 00000252925MR3 850270162 00000007757GQ8 850270167 00000009641GQ2 850270148 00000010192GQ3 850270156 00000010266GQ5 850270158 00000010309GQ3 850270159 00000010311GQ9 850270161 00000010400GQ0 850270163…

Recall started

Jan. 7, 2015

Device type

System, Nuclear Magnetic Resonance Imaging

Root cause (FDA)

Employee error

What the company told customers

GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 60876 dated January 6, 2015 to affected consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. Customers were instructed to do the following: As a preventative measure, confirm that MRU is connected to the magnet by performing the following four step test on the MRU. 1. Verify the green CHARGER POWER LED is lit. 2. Depress and hold the TEST BATTERY switch for 15 seconds. The green BATTERY TEST LED should light and remain lit while the TEST BATTERY switch is depressed. 3. Place the TEST HEATER toggle switch in the A position. The green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. 4. Place the TEST HEATER toggle switch in the B position. Green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. If the MRU test does not perform as described in each of the 4 steps above, GEHC strongly recommends that you stop using the system, and immediately call your GEHC representative. Customers with questions may contact their local service representative. For questions regarding this recall call 1-800-437-1171.

Recall number

Z-1035-2015

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

Source: FDA · Medical device enforcement report, recall number Z-1035-2015. The agency record governs; check it and the company before acting.