FDA · Medical device recall

GE Healthcare Infinia (including Infinia… and 5 more products

Nov. 19, 2014 Class II

Date: Nov. 19, 2014
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, LLC
Distribution pattern: Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.

6 products in this recall

GE Healthcare Infinia (including Infinia…

Product: GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS, H2400YJ, H2400YK. Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Reason: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
Quantity: 2479
Codes and lots: 15012 919684INF1 16089 319356INF 16168 801562JVH02 16074 519749INFINIA2 16061 82426040033 16076 82426040030 16085 82426310015 16158 DK1029NM05 16067 FI1023MN02 16068 FI1153MN01 16141 A5152964 16056 NO1088MN09 16152 00053NUC06 16001 906776INF 16005 615768SCNM1 16015 717782INF 16018 907562NM1 16033 318681INFINIA 16036 920738INF 16043 210921NM1 16045 941637INF 16051 507345INF1 16054 630801INF 16065 860350INIF 16071 763UNTYINFI 16075 937328INF2 16083 973625INFINIA 16084 518828INF 16088 908522INFINIA 16098 203325INF2 16111 956350NM1 16118 814533INF 16123 716366INF 16162 704783INFI3 16166 717627INFINIA 16436 203325INF 16140 110034NU04 16022 905372INFINIA 16039 905731INFINIA 16044 519749INFINIA 16072 450654INF2 16016 M2269829 16092 V2728105 16114 S4160059 16079 783348NU01 16017 HU1039NM02 16126 83026602101643 16135 A5172907 16142 A5197927 16115 850260061 16130 850260060 16170 850260063 18130 2919654INF 16019 MA1154NM02 16106 O005NU14 16049 45001NUC01 16004 00216NUC11 1505 508427INFINIA 10548 608263INF 15010 727461VG 15013 661633NM1 16006 310543INF1 16007 619482INFINIA 16008 509474INFINIA 16009 434924INF2 16010 605333INFINIA 16013 303320IH 16020 775423INF1 16021 928537INF 16026 941629INF 16028 434924INF1 16029 408259IN1 16030 626570INF1 16035 907562NM2 16037 713785SLINF1 16038 LGMCINF2 16046 757668INF1 16050 989723INF1 16052 206223INF 16055 215952INF 16059 916983INFN1 16062 937328INF1 16069 715839INF 16070 225765INF1 16073 989723INF2 16082 516570INF 16109 920684INF 16110 408559IN1 16112 801584INF1 16121 801584INF2 16124 704384HAWK1 16151 603650INFINIA1 16159 937208INF1 16163 615322NM3 16169 858554INF1 16171 409727NM1 16173 508828INF 16097 910266042 16122 910266045 16133 910263135 15006 130139NU02 16040 030209NU02 16128 110022NU03 16027 519752INFINIA 16060 450654INF1 16153 604278INFINIA1 16154 604875INFINIA2H 16138 82426090016 16172 82426160026 16174 82426310025 16024 82426200003 16014 C4191749 16023 M2846905 16101 V8572204 16146 828260005 16066 83026805120043 DUMFMI40849012 IL1020NM25 16148 A5109126 16149 A5115111 16119 HGL0233 16156 ALM0131 16078 NO1016MN16 16103 809758INFINIA 16053 DPN00002 16057 856260023 16120 77137NUC01 16125 00109NUC04 16127 01243NUC02 16131 00361NUC05 16132 01367NUC01 16164 00130NUC03 16120 00137NUC01 16048 316962WI 16058 763MRCYINFI 16081 414384INF 16099 919934INF 16155 585922INF1 16175 626359INF2 16177 626359INF1 16180 504873INF 16182 863687INF1 16184 937208INF2 16185 863687INF2 16186 858554INF2 16189 704384INFI2 16194 704783INFI2 16196 704783INFI1 16208 865947INFINIA1 16209 904821NM1 16212 843724INF 16221 781979INF1 16223 623478NM2 16227 214820INF1 16228 904821NM2 16229 717544INFINIA 16234 601978INF 16235 865545INFINIA1 16239 702369NM 16259 601376INF1 16262 404712INF 16269 262363INF 16271 903731INFINIA 16285 573686INF1 16286 828286INFINIA 16301 937278INF 16303 502868INF1 16305 941235INF 16312 432685DNUC 16319 708747INFACQ 16322 845987INFINIA 16326 941766INF2 16344 517543INF 16354 319768INF 16356 419483NUC2 16372 713359INF1 16378 847535INFACQ 16382 252436INF1 16408 906293INF 16410 ARHINFI 16411 812522INF 16412 352333INF 16413 228436INF 16415 773665INF2 16418 773665INF1 16421 LGMCINF 16422 812485INF 16425 607737INF 16426 610770INFINIA 16429 828696INFINIA1 16437 415222IN1 16441 801357INF1 16442 601936INF1 16443 305835INF 16454 443481INF 16456 804594INF1 16457 845783ORA01 16464 210705NM1 16465 615284INF1 16466 843724INF2 16470 630856INF 16474 417256INF 16475 504873INF2 16475 504380INF 16477 502259INF 16479 843431IN 16489 732292INFINIA 16491 301877INF 16494 479463INF 16497 248898INF 16499 615342INF1 16528 225381INF 16534 319768INF2 16539 214879INF 16541 951696INF1 16542 630275INF 16548 702388VNM 16553 630545INF 16557 215537INFINIA 16559 302428INF 16560 704739INFI 16564 501202INF 16566 405610MINF1 16567 813788INF1 16569 281897INF1 16571 760241INF1 16576 920907INF 16621 502893INF 16628 812842INF1 16640 214324INF 16641 615896NM1 16646 704487INFINIA1 16648 818907INF1 16649 479524INF 16655 435251INF1 16656 770382INM 16658 713785SLINF2 16659 704384INFI5 16660 904819INF1 16661 PITTINF4 16662 229259INF 16665 814723INF 16666 757259INF1 16667 734467INF 16670 801479INF 16672 734671INF 16673 865977INF 16683 225INFINIA 16688 502955INF 16692 305682INF1 16695 607756INF 16696 PITTINF5 16698 262670INF2 16701 541440INF 16710 513454INF1 16712 409985NMI1 16713 904542NM 16715 410337INF2 16724 713242INF2 16725 713242INF3 16734 561744INF 16741 610954INFINIA 16742 402461INF 16746 516IPKINF1 16758 702255INF 16761 828586INFINIA 16762 269657SHINF 16767 912486EGNC 16768 478633INFINIA 16770 217347INFINIA 16772 337436INF 16773 208422INF 16783 813870INF 16786 979532INF1 16789 801465INF1 16790 303839INF 16791 609267INF 16792 305325INF 16796 518262INF3 16798 OBNM1 16800 479751INF 16802 205750INF 16802 518262INF2 16804 352596INF1 16806 423493PINF 16810 518262INF1 16812 CRAVENINF1 16816 410337INF3 16817 479967INF 16819 732530INFINIA 16832 434924INF3 16834 540213INF1 16861 605353NM 16863 415925INF 16864 570836INFINIA 16866 402354INF 16867 404466INF 16868 973971INFINIA 16877 985646INF 16881 210757NM1 16900 479463INF2 16909 FHEINF 16912 441236INFINIA 16918 601288INF1 16920 954735INF2 16923 309344SMNUC 16929 513867INF 16935 901765INFRM8 16937 217544NUC1 16963 209385IN 16964 561650INF1 16965 718948INF 16969 404265INF 16971 704316INFI 16973 972969INF 16983 310319INF1 16984 225658INF 16988 816836CIIN 16991 309655INF1 16993 843689INF 17001 304637INF 17006 985785INF 17007 330721INFINIA1 17010 765456INF 17012 318681INFINIA2 17016 918307INF1 17026 817346INF 17027 920451INF 17036 662772INFRM1 17040 732840INFINIA 17043 805489INF1 17045 662772INFRM2 17054 602588INF 17059 662772INFRM4 17063 772LMCNM2 17064 614478INF1 17073 620225WPI 17074 330721INFINIA2 17075 928214INF 17081 918294INF1 17096 512528NM1 17111 313343INF2 17115 SLGHINF 17117 863679INF1 17119 630312INF 17129 225647INF 17133 256494NM1 17134 330344INFINIA1 17141 207795INFINIA 17142 337943INF 17144 727942INF 17146 228818INF 17150 480324INF 17152 502624INF 17166 931403NM1 17168 843674IN1 17177 248849INF1 17182 256543INF1 17184 931381NM2 17186 404686INF 17188 843832INF 17189 518562INF 17201 618544INF 17205 CRAVENINF3 17211 918494INF2 17212 580931INF1 17216 316858GI 17218 815756INF 17221 203797INF 17223 CRAVENINF2 17224 662423INFINIA 17228 COR373273 17229 607756INF2 17232 724450INFINIA 17235 913541INF1 17239 618993INF 17240 913345INF1 17246 770535INF1 17250 212608INF1 17253 248849INF2 17266 732321INFINIA 17270 580249IN1 17273 605333INF2 17275 770229INF 17279 402449INF 17282 912691SCNC 17283 803329INFIN1 17292 760778INF1 17294 501776INF 17296 843674IN2 17302 518773INF 17304 973877INFINIA 17305 773884INF 17307 718240INF1 17309 850883ENM 17311 318388INF1 17313 843674IN3 17314 662244INFINIA 17315 318327INF1 17320 203852INF 17321 828883INFINIA 17324 516562INFINIA2 17329 254743NM2 17334 724226INF1 17357 978521INF 17359 352344INF 17364 318330INF1 17367 316268VCFI2 17368 786308INF1 17371 713722INF 17380 931967NM 17386 817685INF 17387 707822INFINIA 17393 305227INF1 17394 904202INF1 17396 734475INF 17399 478272INF 17401 615328NM1 17402 706733INF 17403 815432INFINIA 17409 217554CINF 17411 570398INF 17413 864675INFI 17418 727863INF1 17419 COR373282 17424 903785INF 17431 804957INF2 17433 804957INF1 17438 419455INF1 17441 919684INF3 17443 847480INF 17444 412343INF1 17446 806354NWINF 17448 786308INF2 17451 662256INFINIA 17454 248898INF2 17456 323268INF1 17468 859313INF 17471 423625INFINIA 17483 509473INFINIA 17487 419238INF 17489 908522INFINIA3 17501 281637INF 17504 804254INF 17516 618234INF1 17519 843402INF 17521 701364INF 17524 985230INF 17537 303837INF 17538 740383INF1 17542 801479INF2 17550 205759INF 17551 856363INFINIA 17552 313343INF4 17553 816348INF1 17554 773947INF 17555 313343INF3 17556 609835INFINIA 17557 256429INF1 17558 770219INF 17564 727521INF 17584 480323INFRM2 17584 480323INFRM1 17593 703858INF 17605 623882INF 17617 310832INF1 17618 925779IN 17623 970945INF 17630 505863INF 17632 603924INF 17640 262656INF2 17652 305227INF2 17653 740623INFINIA 17657 818884INF1 17660 512324NM 17667 435658INF 17676 618395INF 17684 904821INF3 17687 937440INF2 17695 617313INF1 17698 502350INF 17712 210617NM1 17715 904627INF2 17716 405307INF1 17726 661PMCNUC1 17730 661949NUC1 17734 MVINFNM2 17735 617243INFINIA 17739 602406INF 17744 607762INF 17746 602406OPINF 17748 765552INF 17752 805543INF1 17753 816380CASSINF 17761 904627INF1 17762 814452INF1 17769 708684INF1 17772 805737INF1 17780 NASHNM2 17781 843412INF 17784 540498INF1 17785 865373INF 17787 727581INF 17789 906774INF 17802 843402INF2 17803 865429INFINIA 17806 815432INF 17815 630786INF 17823 406731INF1 17826 618942INF 17834 731644INF 17836 210575INF1 17838 904321INF1 17851 217347INF2 17862 504454INF 17864 941VRMCINF 17866 773995INF 17872 859268INF1 17877 681342INF1 17878 504537INF 17883 985649INF1 17887 681342INF3 17888 443481INF2 17891 681342INF4 17892 GILESINF 17893 985649INF2 17894 681342INF2 17897 302629INF 17899 843606INF1 17900 256327NUC 17901 704355INF2 17902 240566INF 17904 281274INF 17908 701774NM 17909 804225INF1 17910 972394INF 17913 704355INF1 17941 606878INF2 17944 901287INF1 17947 706278INF 17948 828262INFINIA 17957 262687INF2 17958 843777IN1 17962 6502IN2 17964 307332INFINIA 17965 704863INF1 17968 239NCHINF1 17969 708660INF 17970 248471INF 17971 443481BINF 17972 828766INFINIA 17975 757312INF2 17976 860344INF 17980 615349NM2 17981 843777IN2 17984 304831LNM1 17988 615349NM1 17991 913588INF1 17992 CFRHINF 17993 616267INFINIA 17996 843782INF 17997 302733INF 17998 480882INF2 18002 718240INF2 18006 281251SLVINF 18015 774442INF 18017 816392RINF 18027 713794INF3 18029 843692IN1 18030 954978INF1 18048 832522INF 18051 920849INF 18052 832522INF2 18058 435893INF 18059 478454INF 18063 269223VABCINF 18064 281348INF 18065 757312INF1 18066 847990INF1 18067 814643INF 18088 225NOINF 18097 610327INFINIA 18104 885INFI2 18106 325235NUC 18114 951672INF1 18115 704225INF1 18117 405742INF1 18119 319272INF 18120 973831INFINIA 18125 ORMCINFINIA2 18131 885INFI1 18136 518271INF 18138 804281INF1 18142 BCHINF1 18144 954265INF1 18145 317415INF 18146 229333ICINF1 18148 856247INF 18157 205408INF2 18160 859498INF1 18163 229333ICINF2 18164 815395INF 18165 318798INFINIA 18167 571231INF2 18168 571231INF1 18173 573686INF2 18177 210MTINFINIA 18191 805370INF1 18192 704225INF2 18194 303450INF 18201 814333INFINIA1 18203 817472INF 18211 330343INFINIA 18212 814333INFINIA2 18220 615781NM1 18221 409938INF 18222 918502INF1 18223 918307INF2 18225 918494INF3 18226 256341NRM1 18228 904276INF1 18229 609730INF1 18231 727843INF1 18240 910323INF1 18243 980212INF1 18244 609730INF2 18248 817599INF 18250 480512INF2 18251 212562INF1 18254 229SUMINF 18256 406228FINF 18258 937386INF 18260 630275INF2 18267 740922INFINIA 18268 609652INF 18279 405271VAINF1 18284 704446INF1 18285 740264INF4 18289 520868INF 18292 704304INF1 18293 561744INF2 18297 702853NM 18298 218847INF 18309 806354ACINFINIA 18317 605333INF3 18318 605333INF4 18319 479549INF 18320 386326INF1 18321 703391INF1 18322 605333INF5 18324 740264INF3 18328 281274DINF 18335 718518INF1 18339 704304INF2 18344 973579INFINIA 18345 732530INFINIA2 18354 732923INFINIA 18358 419933I1 18364 915595GNM1 18377 704667INF1 18399 760452INF1 18420 586226INF 18432 843797INF1 18446 504826INF 18450 361694DNMINF 18452 937393INF 18463 BRMCINF 18469 435251INF2 18475 865717INF 18480 228523HWK2 18481 843777IN3 18511 918505INF1 18548 908522INFINIA2 18560 610459INF 18336 386362INF1 00000000091BH9 DZ1534NM01 00000000056BH2 DZ1035NM04 00000000059BH6 DZ1035NM03 16381 910264058 16527 910265053 16531 910265055 16685 910264062 16807 910262196 16995 910265059 17051 910264079 17077 910263190 17533 910262234 18118 910264129 16592 AH5689NU01 17911 AH3403NU01 16198 030018NU05 16583 080004NU13 16805 130083NU13 16829 190073NU01 16882 080053NU02 17281 100029NU01 17385 110093NU07 17420 030010NU05 17436 030037NU04 17527 160150NU04 16614 010120NU11 16483 1153389 17628 1299296 17693 2812777 17763 2827087 18031 2883051 18227 NMCR-17980 18232 NMCR-18161…
Recall started: Oct. 14, 2014
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.
Recall number: Z-0184-2015

GE Healthcare Varicam/VG and VG Hawkeye devices…

Product: GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
Reason: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
Quantity: 478
Codes and lots: 0000000010-203 203694MIL 0000000010-191 203852VG 10498 205933VH 10191 206288VG 10262 206598VG 10571 207795VH 10269 208529VG 1078 209334LNVG1 10340 209526milvg 10541 212562VG 1081 225763MVG 000003100-1829 228818MILLVG 00008125-18-18 248338MLO02 10237 248828VG 10326 248937VG 1538 256235OPNM1 10171 262785vg 1039 2894872VG2 1080 2894872VG3 10316 301896VG 10177 304256VG 00000000010-15 304487VG 10156 305612VG 10197 309662SJVG 10539 310231VGH1 10395 312864VG 1058 313299VG 00000000010-63 334794MILVG 1372 361575VG 000000099-4-04 402449SJVG 10189 404605PVGH 1107 407277fvg2 1132 407896FVG1 10211 407933KVG 10438 408947VG 10199 409291HVG 10460 410955VG1 10359 410955VH 10406 412359VG 00000000010-31 413781VG1 00000000010-82 413781VG2 10547 414219VG 10375 414328VG 10534 414384vg 10182 414447VG 3874990 414544VG 5007 414777MIL 10139 414777VG2 10555 414961vg 1141 443643VG 10347 480981NM1 10354 508997VG 10338 510486VG1 1056 512753VG 10481 515263LVG 1035 516256VG 10210 520757NM1 10572 530529VG 10281 540596N3 10190 540953VG 10179 559688NM1 10150 570791HAWK 10193 580355VGACQ 00008125-16-70 58510 00008125-16-89 58582 00008125-18-09 58711 00008125-18-16 58919 00000000017-64 58958 1016 601426VG 10300 602870NM1 10501 605333HAWKEYE 10284 608263VG 10446 608364VG 1119 609267VG 10146 610954VG 1100 615322NM2 10178 615791VG 10041 630801VG 10280 706845VG 10267 707554VG 00000011278NU9 708783VG 3003 714774VG 1126 716694VG 10235 716859VG 1013 718759VG 10263 781278VG 10526 781744VG2 10488 781744VH 10507 804281VG1 00000000010-05 812537VG 10165 813725vg 36478041 813788VG 10307 815842SJVG 10239 828213VG 10398 845437VG 1025 847695MILMVG 10459 847842VG 10143 860343VGOPC 00000000010-30 860344VG 10390 863494VG 10260 904202VG 10435 914734VG 10422 920459VG 10309 920887vg 10445 949760vg1 10222 956632MVG 000003681-1803 970491VG1 1075 978466VG 10357 978741VG 10218 979764VGH1 10409 FHORLVGH1 1046 MAYO4VG3 10491 NM73049 10353 NM81394 10180 RADNETNM1724 10530 509575PYVGH 00000000010-54 203932VG 00000000018-24 59012 5004 912633MCVG 000003100-1840 919684VG1 00000000010-50 MAYO1VG4 10256 MAYO1VGH1 1113 973754VG 00008125-38-18 58993 10288 912764VG 10569 NM10569 10291 NM10291 10174 NM10174 10473 910265011 10028 AH0101NM02 10392 AH0101NM03 10129 AH3701NM04 10302 AH4307NM04 10576 AH4660NM05 10518 110012NU02 10224 110965NU05 10590 160070NU01 DUMFMI40849016 190226NU17 10475 030082NU10 00000000010-45 030355NU02 00000000017-27 030010NU02 10493 220166NU01 00000000017-15 030151NU05 00000000016-17 030388NU01 10339 080041NU01 10172 030028nu01 10568 030220NU02 1111 92635 1034 79722 10367 12865 343 0343A 000003100-1763 0360A 10166 38070 61061 61061 00000000010-04 63422 10173 66515 0000D4360X4372 6970 00000000030-11 73240-1 10374 NM10374 10378 NM10378 1649 0112B 10377 84636 1021 56948 1019 75074 00000000010-67 0277A 1074 99691 1042 79966 10040 204837HK1 1289 416284VG 0000000010-134 416284VG2 10175 416290VG 10164 416444VG 10384 416469DVH 1010 416534VG2 1072 416586VG 10146 416656vg 10133 416747VG 10449 416756VG 10283 450359VG1 10295 450359VG2 10410 514495VG 10169 613548VG 10276 613548VG2 1066 705324VG 00000000017-10 705327VARICAM 10209 705652VG 10376 807343BMILLVG 10381 807343CMILLVG 10244 819563CVG 1756 819822VG 10420 905527HAWKEYE 10332 905683VG 10216 905845VG 10454 905846VG 000003100-1719 905848VG 10124 905855VG 10158 905883VG 10396 82426160016 10606 82426180003 10287 82426010009 10514 82426010010 10522 82426010011 10176 82426030009 10268 82426030010 10206 82426030016 10564 82426030018 10328 82426040020 10264 82426040021 10456 82426040024 10486 82426040026 10489 82426040029 10342 82426050001 10562 82426050002 10589 82426050003 10520 82426070016 10368 82426090013 10424 82426100019 10434 82426100020 10448 82426100023 10240 82426140007 10402 82426140009 10487 82426140011 10249 82426160014 10403 82426160017 10428 82426160019 10531 82426160022 10313 82426190008 10397 82426190010 10598 82426200002 10574 82426230010 10450 82426250002 10591 82426280001 10483 82426290004 1155 82426310005 10303 82426100017 10519 82426040025 10550 82426070015 10439 82426080006 10363 82426080007 10599 82426080009 10548 82426110002 10314 82426120003 10297 82426120004 10401 82426130012 10250 82426130015 10401 82426130019 10121 82426140005 10400 82426140008 10540 82426140012 000003100-1743 82426150003 10207 82426150006 10194 82426160012 10476 82426160020 10584 82426160023 10204 82426210003 10595 82426210010 10594 82426220006 000003100-1760 NM3100-1760 10360 CY1088MN04 00000000017-47 CS1341NM01 DUMFMI40849019 DK1026NM05 00000000010196 EE1020MN01 10196 EE4020MN01 10345 M2846904 1144 M5400305 1086 A2846901 10559 M4024091 10527 M4134620 10243 M4144845 10558 M4143939 10325 M4160707 00000000016-71 540186NU01 DUMFMI40849010 580505NU01 10282 CC0618NU13 10229 HC2250NU01 10254 HC2250NU02 10251 HC2250NU03 10485 HC3314NU01 10168 HC4387NU01 10457 HJJT01NU02 10355 HT2106NU05 DUMFMI40849009 PC0173NU06 00000000010-59 PC0396NU03 1076 PC2306NU01 10505 PC4178NU01 10431 UC1129NU01 10495 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10512 NO1015MN03 10388 NO1016MN27 1687 NM0382E00013 00000000017-20 600062NM01 00000000017-22 PL1008NM01 00000000017-23 PL1003NM01 10352 PER10924 10346 PER10925 10529 PMR12503 10515 PER02544 1617 1617 1061 NM1061-MVG 00008125-16-25 NM8125-16-25 10115 10115 000003100-1838 NM3100-1838 000008125-1630 NM8125-1630 1008 NM1008-MVG 10103 787782VARICAM-1 10414 RU1100NM01 10561 RU1591NM01 10553 RU1457NM01 10461 RU1704NM01 10494 SK1071NM01 DUMFMI40849005 SK1082NM01 10417 DE282013 10334 DE619831 DUMFMI40849011 DEL26415 10323 EEF51528 10425 FE416038 10270 FE816127 10426 FEB52048 1101 GEC21815 10453 GEE34020 10343 ME260802 10348 ME612431 10533 MPX24714 10412 YE645816 10405 YE645817 10382 ME504345 10468 A004NU10 10560 E001NU09 10463 G001NU07 1890 U001NU12 10581 853940082 1065 853940069 1998 853940077 1999 853940078 00000000016-86 856260014 00000000017-31 856260019 10195 16003NUC03 00000000017-36 06007NUC16 000003100-1744 UK1135NM01 10333 00584NUC01 00000000018-40 00222NUC01 00000000010-01 00023NUC06 10516 00243NUC11 10551 00243NUC15 10556 00243NUC17 10379 00269NUC07 UNKASM00109201 00357NUC02 00000000010-64 70050NUC06 10462 10433nuc01 10557 00216NUC09 000003101-1502 20091001VG
Recall started: Oct. 14, 2014
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.
Recall number: Z-0185-2015

Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system…

Product: Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.
Reason: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
Quantity: 255
Codes and lots: 21111 DUKECCDSV670NM 21189 DUKEDMP670NM 21223 307362D670 21224 660890D670 21079 0910267022 00000000103BH2 0910263259 00000000124BH8 83092327843 00000000129BH7 83092719500 00000087514HL6 83092962829 00000097761HL1 83095572382 00000333837HM3 83091096402 21215 100039NU02 21229 210002NU11 21220 BY4033NM01 21166 82426070031 21213 82426040052 21222 082426040053 21231 082426070034 21230 082426080022 21226 TP0007NU02 21155 IE1018MN03 092302HL9 KW1001NM01 092303HL7 KW1112NM04 092307HL8 KW1112NM03 21148 ZWL0630 00000093649HL2 QA1064NM01 21173 RU2581NM01 21190 RU7174NM01 00000290644HM4 RU1493NM01 00000322039HM9 SA1006NM01 095718HL3 SA2315NM01 21219 0847260029 21218 M001NU43 21177 475260NU01 21234 00242NUC06 SAN00200 00258NUC02 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21114 614NCH670 21127 410D6701 21149 540332D670 21157 856247D670 21172 630432D670 21188 415353D670 21193 610402D670NM1 21201 720848D670 21202 972747NM670 21221 410955D670 SAN00215 615893MMCT1 21002 0910263235 21013 0910263223 21017 0910262297 21020 0910262304 21029 0910263228 21039 0910263231 21041 0910262310 21049 0910263243 21066 0910262319 21075 0910262322 21080 0910263239 21081 0910264141 21082 0910262325 21119 0910264135 21140 0910265075 21144 0910265074 21145 0910262344 21147 0910264147 21150 0910263250 00000000096BH8 0910265076 21001 010120NU19 21008 110022NU05 21034 030133NU13 21050 210060NU02 21056 110017NU06 21104 030082NU13 21132 100032NU05 21162 190163NU04 21167 190163NU06 21178 080041NU04 21179 030360NU01 21214 030037NU08 210088 190052NU09 21164 BG4009NM01 21042 204726D670NM 21048 514848D670 21058 AM1-122ANKH9 21061 514281D670 21077 514842AD670 21085 905883D670 21094 519973D670 21115 613548D670 21122 418549D670A 21123 418549D670B 21135 905684D670A 21137 514338D670 21139 905684D670B 21143 250370D670 21156 905472D670 21184 403943D670 21194 403943D670B 21198 819563D670B 21200 403343D670 21210 514876D670 000CZC11601GV 416495D670 21028 082426130029 21052 082426070028 21076 082426080020 21083 082426040043 21092 082426070030 21101 082426130030 21113 082426040044 21118 082426090029 21131 082426150026 21138 082426090030 21165 082426210020 21183 082426160042 21207 082426230020 21212 082426100052 21158 082426060005 21168 082426040051 21019 DK1029NU14 21055 DK1047NM01 21154 EE1020NM03 21009 FI1052MN01 21021 M4210246 21022 X102874005 21033 M4134637 21035 M9409545 21037 M4198090 21063 M4505290 21064 M5172553 21067 M9886847 21070 M2002713 21073 X4144501 21086 M4143630 21095 M4476424 21121 M5480777 21128 M251400603 21134 A4194844 21141 A4169312 21146 M4145158 21152 V4144610 21153 M5400562 21159 M4215577 21186 M4194042 21187 M4144126 21197 V4169306 21206 M4143993 21216 B4182011 21024 UX2305NU01 21196 PC8262NU01 21093 GP1000NM01 21170 0828260021 21199 0828260022 21004 083026201006810 21014 083026009408410 21053 083026023683711 21031 IL1041NM30 21129 IL1062NM29 00ME1 IL1020NM36 21012 A5129983 21059 A51142126 21151 B5140618 21163 A51051127 21185 A5125139 21205 A5196344 21089 NT1001 21097 NT1002 21100 NT2001 21136 NT1006 00000000081BH0 NT1003 00000000082BH8 NT1004 00000000092BH7 NT1005 00000000093BH5 NT1007 00000000101BH6 NT1010 00000000102BH4 NT1011 00000000106BH5 NT2002 00000000110BH7 NT1020 00000000111BH5 NT1009 00000000122BH2 NT1013 00000000123BH0 NT1015 00000326277HM1 NT1012 21016 0850260118 21040 0850260122 21060 0850260131 21103 0850260128 21125 0850260132 21038 RTD0737 21204 AMS1330 21209 HOR0281 00000000118BH0 0920269097 21068 NO1087MN09 21126 NO1018MN06 21211 NO1088MN16 21026 600092NM11 21011 RU3451NM01 21018 RU3637PT01 21025 RU3623NM01 21071 RU3713NM01 21087 RU1949NM01 21090 RU3900NM01 21098 RU7505NM01 21109 RU7187NM01 21110 RU6340NM01 21130 RU7175NM01 21142 RU1095NM03 21160 RU3467NM01 21161 RU3880NM01 21180 RU1279NM02 21195 GON4061978 00000093077HL6 SA1034NM01 00000321622HM3 SA2281NM01 21007 MEX68915 21047 FE416061 21175 D007NU12 21203 M001NU42 21217 O005NU27 21005 529150NU05 21072 900010NU09 21191 260010NU06 21099 0853260094 21171 0853260099 21096 0856260034 21107 0856260033 21169 0856260035 21091 06007NUC19 21003 00200NUC07 21006 00200NUC08 21010 00361NUC08 21027 00046NUC06 21036 00042NUC02 21043 10497NUC20 21046 00065NUC08 21051 00028NUC01 21084 00001NUC12 21108 00197NUC14 21116 00199NUC13 21120 11018NUC08 21124 00432NUC02 21133 00123NUC01 21176 00234NUC09 21181 05462NUC05 21192 00271NUC07 21208 00149NUC03 21225 00310NUC06 21227 00149NUC01
Recall started: Oct. 14, 2014
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.
Recall number: Z-0186-2015

Discovery NM 630…

Product: Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.
Reason: GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being added to prevent a portion of the system falling onto the patient during a scan due to fasteners being loose that secure the camera to the gantry.
Quantity: 147
Codes and lots: 22002 619474D630 22004 618443DISC1 22007 814623D630 22010 251639D630 22012 704355D630 22013 956523D630 22017 845454D630 22018 618842DISC1 22024 601354D630 22025 773282D630 22026 813558D630 22027 941LWRNM630 22029 PRINCE630 22030 281540D630 22032 417781D630 22033 601288D630 22034 913345D630 22036 318798D630 22039 614NCH630 22040 904321DSC1 22041 317887D630 22042 318448D630 22043 JHDSV630NM 22045 217544PH630 22046 301877D630 22047 601798D630 22048 716372NM630 22049 580531NM630 22050 651DSC630 22052 205333D630 22053 618942NM630 22054 813615D630 22055 719587D630 22056 903GSD630 22057 417533D630 22058 708684D630 22059 937SNHC630 22063 707961D630 22064 918502DIS1 22065 804675D630A 22066 469814NM630 22067 978354DSV630 22068 585922NM630 22069 305596D630A 22070 956523D630 22072 POIN630 22077 816234D630 22081 808485NM630 22082 989227D630 22085 305596D630B 22087 801714D630 22088 815564D630 22091 702388VNM2 22092 760778D630 22094 269945D630 22095 843347D630 22096 201418D630 22097 319364D630B 22098 207664NM630 22099 334287NM630 22101 609978D630 22103 843797TD630 22105 319364D630A 22112 OSC630 22117 330386D630 22119 909599D630 22122 904276DSC1 22123 270417D630 22124 901226D630 22125 208455NM630 22126 409212NM630 22127 770751D630 22131 DMP630A 22132 936NMD630 22134 856355D630 22135 DMP630B 22136 605322D630 22137 775STMANM630A 22138 951303D630 22139 850862D630 22141 765447D630 22143 203384D630 22144 WH231NM630 22145 603354NM630 22148 302430NUC630 22149 229259D630 22150 910FHHOKENM630 22151 479967DSC 22156 607763DIS630 22163 262798D630 00107BH3 DZ1060NM01 22090 NM22090 22003 030359NU07 22038 030029NU05 22080 030151NU15 22073 NM22073 22074 NM22074 22118 NM22118 22120 NM22120 22130 NM22130 22051 905684D630 22114 514843AD630 22102 NM22102 22116 NM22116 22129 NM22129 22161 NM22161 00000000083BH6 EG1040NM01 22014 M4216453 22016 M4476428 22079 V6414107 22084 M45052111 22121 M2148252 22001 TP0004NU01 22011 PMAB01NU04 22023 PC3003NU01 22078 407431NU01 22089 HC0863NU02 22108 870939NU02 22109 870939NU01 22115 600791NU01 22140 HG4437NU04 22147 HC0038NU01 22107 H3001NUC01 22005 083026001113611 22133 083026200011213 22021 IE1044NM01 22022 A5384208 22031 A5812287 22035 A5131865 22086 A5366307 22044 NT1008 22071 NT3010 22104 NT3002 22110 NT3003 22111 NT3020 CZC1321LZ6 NT3001 22037 0850260134 22093 0850260125 22009 NO1035MN06 22083 RU1136NM01 22106 ZA2029NM01 22075 H002NU03 22113 O009NU09 22128 34363NUC01 22015 00001NUC11 22028 00052NUC11 22100 00271NUC10
Recall started: Oct. 14, 2014
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.
Recall number: Z-0187-2015

Optima NM/CT 640…

Product: Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies
Reason: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
Quantity: 29
Codes and lots: 25018 816234D640 26004 815564O640 26007 817250NM640 26010 717782640NM 26012 808485NM640 26013 847872O640 26014 901516GO640 26018 270956NM640 26020 309672NM2 26021 215728OPT640 26025 410543NUC640 26026 928214NMCT 26028 715735OPT1 26002 0910263256 26005 0910263253 22020 030232NU15 26009 DK1054NM03 26001 XM203401 26003 ULUE01NU02 26015 915839NU01 26024 083026800008113 26006 A5639613 26008 A5366308 25023 RTD0782 26030 NM26030 26023 BD003NU01 26017 00162NUC11 26019 00203NUC06 26022 00139NUC08
Recall started: Oct. 14, 2014
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.
Recall number: Z-0188-2015

Brivo NM615…

Product: Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories
Reason: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
Quantity: 22
Codes and lots: Mfg Lot or Serial # System ID 24013 702304NM615 24001 406222LN615 24003 478272NM 24004 405456NM615 24006 806665NM615 24019 030151NU17 24011 NM24011 24014 NM24014 24020 NM24020 24015 NM24015 24016 GON1427120 24002 HC0541NU03 24009 387171NU01 24010 HC3366NU02 24007 083026241010212 00000000116BH4 083026040018413 00000000117BH2 083026020020313 24008 A5635609 24017 NM24017 00000000084BH4 PK1267NM01 24005 ZA2446NM01 24012 ZA1819NM04
Recall started: Oct. 14, 2014
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.
Recall number: Z-0189-2015

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0184-2015, Z-0185-2015, Z-0186-2015, Z-0187-2015, Z-0188-2015, Z-0189-2015. The agency record governs; check it and the company before acting.

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