Devices

Device Recall GE PET/CT System

  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00001035638YM4 082421010179 00000001887YC9 082421010327 00001035639YM2 082421020108 00001035636YM8 082421020109 00001031633YM9 082421030253 00001031634YM7 082421030254 00000003852YC1 082421030266 00001031640YM4 082421040157 00001035634YM3 082421060051 00000001885YC3 082421060054 00001035641YM8 082421080078 00001031632YM1 082421090164 00001035640YM0 082421090168 00001031639YM6 082421100318 00001031638YM8 082421120200 00000003853YC9 082421140187 00001031637YM0 082421150068 00000001883YC8 082421200244 00000001888YC7 082421270069 00001035633YM5 082421310091 00000001891YC1 082421040171 00000001892YC9 082421040177 00000001889YC5 082421090174 00000001890YC3 082421090175 00000001886YC1 082421310106
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    LightSpeed Ultra (8-slice MDAS), 5120327-3 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
    GE Medical Systems, LLC
  • 1 Event

Fabricant

GE Medical Systems, LLC
  • Adresse du fabricant
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA

5 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

Device Recall GE PET/CT System
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000002631PT0 4860AW442 00000002631PT0 4860AW442 00000318118CN7 0910213115 00000002808PT4 0910453003P 00000318118CN7 0910213115 00000318118CN7 0910213115 00000980093YM9 0910212119 00000002247PT5 090016PT01 00000326200CN3 110012CT01 00000311426CN1 030018CT01 00000002103PT0 2728449 00000003306PT8 2757760XXX 00000003306PT8 2757760XXX 00000003310PT0 47867 00000002103PT0 2728449 00000002103PT0 2728449 00000339630CN6 BG4029CT01 00000298328CN6 204787LS1 00000298660CN2 204787LSPD2 00000307018CN2 416249LS16 00000309304CN4 519744LS16 00000309524CN7 819379LS 00000310680CN4 418862LS 00000312264CN5 450656LS 00000316257CN5 613761LS16 00000317195CN6 604988LS16 00000318444CN7 514499LS 00000318927CN1 514468BLS 00000319310CN9 519421LS16 00000324459CN7 450466LS 00000328940CN2 450654LS 00000329994CN8 819561LS 00000332076CN9 506648LS16 00000335314CN1 514934CLS16 00000341799CN5 416284LS16 00000341801CN9 416744LS16 00000341802CN7 905883LS16 00000347191CN9 450778LS 00000348810CN3 416924DST 00000349405CN1 514934BDST 00000994091YM7 418549LS 00000334561CN8 26329CT4X 00000002642PT7 082445310001 00000002660PT9 082445310003 00000340577CN6 082421120176 00000340630CN3 082421140148 00000989604YM4 082421030247 00000989603YM6 082421040128 00000989606YM9 082421080068 00000989606YM9 082421080068 00000989602YM8 082421100277 00000989607YM7 082421210116 00000352887CN4 USONCDST16 00000346880CN8 2532905LIG16 00000295643CN1 FI1017CT02 00000334897CN6 A9190135 00000001843PT2 B4155412 00000334897CN6 A9190135 00000002494PT3 GOLD010013 00000341585CN8 GOLD010316 00000336468CN4 M4143946 00000002494PT3 GOLD010013 00000339849CN2 M4215541 00000339849CN2 M4215541 00000336833CN9 M4434860 00000341585CN8 GOLD010316 00000341585CN8 GOLD010316 00000341585CN8 GOLD010316 00000001843PT2 B4155412 00000293499CN0 M5481223 00000302751CN3 M4516011 00000309305CN1 M4491923 00000310268CN8 M4191025 00000313650CN4 C6010809 00000326112CN0 M1279722 00000329304CN0 X993729001 00000980112YM7 M4490502 00000317863CN9 GOLD002055 00000297427CN7 GOLD001604 00000031399CN5 CC0618CT03 00000313999CN5 CC0618CT03 00000988382YM8 HC4912CT02 00000330530CN7 0828210047 00000339850CN0 IS1001CT01 00000339850CN0 IS1001CT01 00000002861PT3 0002740730 00000002861PT3 0002740730 00000002861PT3 0002740730 00000334896CN8 0835210046X 00000002164PT2 IL1020NM18 00000980121YM8 IL1082CT02 00000002389PT5 A5128738 UNK22863270001 A5148558 00000317806CN8 A5152959 00000334895CN0 A5177358 00000325622CN9 A5269709 00000334875CN2 A5696306 00000003599PT8 A5645905 00000339627CN2 B5119111 00000339627CN2 B5119111 00000002207PT9 C5126802 00000003008PT0 YH0011 00000003080PT9 YH0012 00000002826PT6 YH0015 00000002969PT4 YH0016 00000003247PT4 YH0017 00000003662PT4 YH0019 00000003973PT5 YH0025 00000003972PT7 YH0026 00000004113PT7 YH0028 00000003102PT1 YN1033 00000327052CN7 QV0023 00000989605YM1 XF0149 00000001950PT5 YH0008 00000002711PT0 YH0010 00000002664PT1 YH0014 00000003663PT2 YH0020 00000003733PT3 YH0020 00000003733PT3 YH0020 00000003734PT1 YH0022 00000003732PT5 YH0023 00000004107PT9 YH0033 00000292947CN9 QW2004 00000294147CN4 QZ0009 00000294768CN7 QW2005 00000298361CN7 QX0014 00000298654CN5 QW2009 00000298785CN7 QZ0008 00000301211CN9 QZ0006 00000303436CN0 QY0017 00000307949CN8 QW3031 00000313364CN2 QW3041 00000988392YM7 QW3080 00000941023YM4 QW3078 00000941023YM4 QW3078 00000953832YM3 QT3035 00000980119YM2 QZ0020 00000345972CN4 0850210561 00000339481CN4 LV4000CT01 00000002663PT3 LB1077MN01 00000318890CN1 LT4000CT01 00000328801CN6 LT4001CT01 00000345987CN2 030013CT04 00000324061CN1 NO1016CT04 00000324061CN1 NO1016CT04 00000002442PT2 0843450002 00000338649CN7 PPR05009 00000002051PT1 MPX33107 00000339848CN4 O005CT06 00000315961CN3 Z001CT02 00000327581CN5 Z001CT02 00000345782CN7 120928CT01 00000314376CN5 260010CT13 00000002163PT4 529150PE01 00000315054CN7 547090CT05 00000345782CN7 120928CT01 00000314530CN7 725030CT01 00000341587CN4 794130CT02 00000002163PT4 529150PE01 00000315054CN7 547090CT05 00000296274CN4 501030CT02 00000323859CN9 259130CT02 00000346701CN6 900010PE08 00000003006PT4 0853450002 00000003004PT9 0853450003 00000002699PT7 0853450004 00000309505CN6 00243CTS06 00000309505CN6 00243CTS06 00000309505CN6 00243CTS06 00000003709PT3 10094PTM62 UNK22863270000 10094PTM62 00000003709PT3 10094PTM62 00000312815CN4 10458CTS01 00000318595CN6 00537CTS01 00000317863CN9 GOLD002055 00000341584CN1 315329CT16 00000341584CN1 315329CT16 303586CN2 SHICT24 311423CN8 559686DGCT1 309307CN7 SHICT18 318593CN1 MHOPSPLS16 297597CN7 MHOPFWCT1 311813CN0 281283MCLCT 311057CN4 713MHNWLS16 298358CN3 912486GECT 00000334468CN6 361PRMPKDL 304685CN1 210572TOLS16 329303CN2 MPXLS16 00000341884CN5 SHICT66 342627 509575YM16CT 00000277800CN9 415723SCT3 00000284984CN2 630352DST 00000288654CN7 703385LS16 00000292531CN1 423272CT 00000293011CN3 CT81441 00000293033CN7 CDISCT1 00000293034CN5 419584CT 00000293036CN0 352597PET 00000293037CN8 631475LS16 00000294043CN5 919BCLS16 00000294051CN8 312266L16 00000294344CN7 504873TL16 00000294345CN4 SMGCT15 00000294503CN8 770718OCT1 00000294504CN6 949760CT2 00000294506CN1 315464CT16 00000294765CN3 251368ACT 00000294766CN1 402481BWCT1 00000294857CN8 512AERNCT 00000294858CN6 RADNETCT443 00000294996CN4 404616QXI 00000295003CN8 561989CT4 00000295004CN6 509946LSCT 00000295005CN3 785452SCT 00000295006CN1 404732QXI 00000295116CN8 302738LS16 00000295119CN2 608263CT1 00000295120CN0 225769RGLS1 00000295121CN8 469525DLS 00000295122CN6 713932MCT3 00000295123CN4 814238LS1 00000295124CN2 502560ULT3 00000295125CN9 662841CT1 00000295410CN5 919731CT16 00000295416CN2 314768SMCT 00000295418CN8 903ADVCT16 00000295641CN5 920568CT16 00000295642CN3 805988GICT 00000295882CN5 727372LS16 00000295883CN3 704487LS16 00000295884CN1 916RICCT16 00000296271CN0 414541QXI4 00000296272CN8 518828CT 00000296275CN1 214705FCER 00000296277CN7 225761CT1 00000296279CN3 949631CT1 00000296280CN1 805SVCT1 00000297008CN5 415929KCT 00000297382CN4 206232CT1 00000297422CN8 ALLIANCECT66 00000297424CN4 317962LSP1 00000297425CN1 770677DST 00000297426CN9 412777LS16 00000297461CN6 903757QXI16 00000297464CN0 864716CTU1 00000297601CN7 925KWCCT2 00000297899CN7 603650LS16 00000297901CN1 203852CT16 00000297903CN7 315332CT16 00000297993CN8 702616CT 00000297994CN6 845783ORA01 00000297996CN1 281FCDPCT 00000298320CN3 909558CT4 00000298326CN0 262785CT3 00000298345CN0 734240CT16 00000298360CN9 210292LSA 00000298362CN5 404875QXI 00000298363CN3 281OBMCCT 00000298367CN4 662841CT2 00000298656CN0 321434HRCT2 00000298657CN8 214879L16A 00000298658CN6 214820NPLS16 00000298786CN5 817377LS16 00000298789CN9 RADNETPT611 00000298790CN7 ALLIANCECT67 00000298791CN5 317274ROCLS 00000298793CN1 847LS16CT1 00000299039CN8 936271CT1 00000299040CN6 315464UBJCT 00000299041CN4 304526LS16 00000299078CN6 813932LS16 00000299234CN5 RADNETCT1500 00000299311CN1 910215MR16 00000299312CN9 208354CT 00000299313CN7 SMGCT36 00000299484CN6 480820CT16 00000299485CN3 913676SLS16 00000299487CN9 586493H16 00000299763CN3 208467CTLS 00000299764CN1 FHOMPOPC1 00000299765CN8 703578LS16 00000299767CN4 850434BCT1 00000299768CN2 409899LS03 00000299933CN2 SHICT251 00000299950CN6 858939CT1 00000299954CN8 RADNETCT1447 00000300246CN6 704783LS16 00000300247CN4 515263CT1 00000300371CN2 573635SMCT2 00000300373CN8 702877CT1 00000300374CN6 503674CT 00000300490CN0 ALLIANCECT136 00000300854CN7 605882CT 00000300855CN4 702228CT 00000301082CN4 718334LS01 00000301083CN2 903594OLS 00000301084CN0 914737CTLS 00000301086CN5 312423LS16 00000302752CN1 718334LS02 00000303081CN6 913588KQXI 00000303515CN1 662841CT3 00000303581CN3 513867CT 00000303584CN7 301759CT16 00000303585CN4 651254CT3 00000303588CN8 973926LS16 00000303590CN4 404321QXI 00000304110CN0 303427LS1 00000304113CN4 276666CT 00000304156CN3 87FERMANCT 00000304157CN1 602277CT16 00000304159CN7 805988PET1 00000304684CN4 714633CTM 00000304687CN7 970244AMPCT 00000304688CN5 708342LS16 00000305240CN4 SHICT60 00000305525CN8 314919HWCT 00000305526CN6 305325CT4 00000305946CN6 201599DST 00000305947CN4 SMGCT33 00000305950CN8 SHICT61 00000307017CN4 412647QXI2 00000307019CN0 518262LS16 00000307020CN8 502226LS16 00000307021CN6 928779CT1 00000307023CN2 662244L16 00000307024CN0 956969CT 00000307025CN7 405247LSP 00000307026CN5 847437ACT4 00000307944CN9 303SKYLS16 00000307950CN6 305682LS2 00000307951CN4 516773CT 00000307952CN2 303AMIMCT1 00000308142CN9 801588CT2 00000308143CN7 239AHCLS16 00000308144CN5 813751LS16 00000308145CN2 303440LS2 00000308359CN9 979ALJCT 00000308360CN7 336713BCT2 00000308361CN5 972420LS16 00000308362CN3 260373ERLS 00000308364CN9 937352LS2 00000308611CN3 936637WH16 00000308612CN1 719264LS16 00000308613CN9 260672LS 00000308615CN4 908979CT 00000308734CN3 843792CT3 00000308835CN8 205877B16 00000308836CN6 214345LINUX16 00000308838CN2 310423LS16 00000308839CN0 309672MCT1B 00000308841CN6 303788CT16 00000308842CN4 813870LS16 00000308980CN2 270745MCLS2 00000308981CN0 574237LS16 00000308983CN6 918494SFLS2 00000308985CN1 918494OCT1 00000309303CN6 830643MDLS 00000309520CN5 941629LS16 00000309957CN9 724284CTLS16 00000309958CN7 936MMCSACT16 00000309962CN9 970350LS1 00000310119CN3 650552DLS 00000310123CN5 214820CT16 00000310124CN3 RADNETCT1470 00000310263CN9 513561CT 00000310265CN4 262673CT16LS 00000310267CN0 715453CT1 00000310269CN6 708216L16 00000310683CN8 256233LS16 00000310729CN9 INSIGHTCT3208 00000310730CN7 908725LS16 00000310731CN5 904391CTLS 00000310733CN1 804320LS1 00000310734CN9 212230LS16B 00000310877CN6 469454LS16 00000310878CN4 252522LMCT1 00000310880CN0 803296CT2 00000311051CN7 651220LS 00000311053CN3 617724CT04 00000311055CN8 502781UL16 00000311417CN0 281274CT3 00000311419CN6 SHICT289 00000311424CN6 770751QXI 00000311425CN3 972412LS16 00000311810CN6 763588SPCT 00000311814CN8 765825LS 00000312255CN3 954927LS1 00000312257CN9 503215PCT4 00000312258CN7 631476LS16 00000312259CN5 770732QXI2 00000312260CN3 972498L16A 00000312262CN9 718518LS1 00000312263CN7 SHICT68 00000312923CN6 773282LS16 00000312926CN9 214250LS16 00000312927CN7 303248LS16 00000312928CN5 985230LS16 00000313098CN6 415353SFCT 00000313363CN4 765423LS16 00000313365CN9 706845WGLS 00000313366CN7 941637DLS 00000313370CN9 434243UVICT1 00000313646CN2 713776MHSW3 00000313647CN0 256737CM16 00000313649CN6 423586CT2 00000313652CN0 817465L16A 00000313654CN6 303AILS16 00000313916CN9 916787CT 00000313919CN3 503216SCT4 00000313920CN1 386FHDCT2 00000314490CN4 631444CT1 00000314491CN2 252847CT3 00000314494CN6 713566LCT2 00000314496CN1 706246RCT 00000314621CN4 423431CT2A 00000314633CN9 816276BLS 00000314637CN0 215248LS16 00000314639CN6 479963LS16 00000314950CN7 913541CT16 00000314952CN3 718918LS16 00000314953CN1 402826CT 00000314954CN9 913345MCT 00000314955CN6 RADNETPT1813 00000315224CN6 414489LSCT1 00000315225CN3 SMSHIL1 00000315226CN1 804330SFOLS16 00000315227CN9 607734H16 00000315228CN7 209526CT16 00000315229CN5 815599LS16 00000315230CN3 757345GECT 00000315231CN1 757363CTLS 00000315233CN7 928758LSCT 00000316258CN3 INSIGHTCT3225 00000316259CN1 210351MSDLS 00000316362CN3 402481PLMCT1 00000316363CN1 402JPAC16 00000316364CN9 253426CT 00000316366CN4 281897CLS1 00000316660CN0 402887CT16 00000316661CN8 702451DLS 00000317095CN5 973754LS 00000317095CN8 973754LS 00000317097CN4 239262DLS 00000317098CN2 972596LS16 00000317100CN6 Not Available 00000317101CN4 214618LS16 00000317567CN6 847855LS16 00000317568CN4 214647LS16 00000317787CN0 228377LS16 00000317788CN8 ALLIANCECT127 00000317790CN4 612863LSC 00000317977CN7 920846LS16 00000318116CN1 423778EP16 00000318312CN6 512901CT1 00000318313CN4 301877LS16 00000318314CN2 949949CT 00000318443CN9 610645LS16 00000318591CN5 309680CT 00000318875CN2 469312LS16 00000318876CN0 918683LS16 00000318884CN4 ALLIANCECT118 00000318928CN9 706494DCT 00000319304CN2 601200CT1 00000319306CN7 95663216CT 00000319307CN5 435251CT 00000319946CN0 541963GCT 00000319947CN8 630801LS16 00000319949CN4 904928CTLS 00000319950CN2 360417CT 00000319951CN0 314467TFCT 00000319953CN6 757886CT 00000319954CN4 847723LS3 00000319955CN1 435722CT 00000320549CN9 813757LS16 00000320666CN1 972548LS16 00000320667CN9 281PERWCT 00000320668CN7 724537CTLS 00000320670CN3 323442CT 00000320671CN1 985639LS16 00000320673CN7 972270FCER 00000321160CN4 832321AGCT 00000321161CN2 RADNETCT1455 00000321162CN0 760775CT 00000321323CN8 336651WCT 00000321324CN6 SHICT54 00000321588CN6 626335CT 00000321963CN1 610648LS16 00000321965CN6 972498FCER 00000321966CN4 732671LS16 00000322334CN4 914366LS16 00000322335CN1 701774LS 00000322339CN3 701456CT 00000323048CN9 WMHLS16CT1 00000323049CN7 865693CT2 00000323050CN5 781340SCT4 00000323203CN0 510295CT16 00000323204CN8 321799CT1 00000323257CN6 979MGHCT16 00000323309CN5 417269LS16 00000323311CN1 847985LS16 00000323312CN9 626814CT 00000323314CN5 321OMNIDLS 00000323316CN0 740393CT16 00000323329CN3 217383CCT5 00000323330CN1 804864BRLS16 00000323857CN3 414527CT1 00000323860CN7 ALLIANCECT74 00000324461CN3 805546CT1 00000324963CN8 662841CT4 00000324964CN6 FHPKAPHC1 00000324986CN9 440816LS16 00000325187CN3 316722WWCT 00000325189CN9 936292PER 00000326110CN4 302421LS16 00000326582CN4 281837DST 00000326583CN2 972384LS16 00000326584CN0 760739DLS 00000326659CN0 610526LS16 00000327080CN8 858626LSCTM16 00000327270CN5 509434VACT 00000327816CN5 918307SHLS 00000327817CN3 706802CT1 00000328245CN6 706378LS16 00000328246CN4 918556PETCT 00000328356CN1 814437LS16 00000328358CN7 4147614XCT1 00000328361CN1 334705EACT 00000328362CN9 510752CTM 00000328911CN3 724772CT1 00000328924CN6 333NFCT 00000328925CN3 210FCTEZ16 00000328927CN9 248898DST 00000328941CN0 WCRLS16ORL 00000329236CN4 580765CT 00000329301CN6 RADNETCT464 00000329302CN4 570321CT2 00000329985CN6 703698LS16A 00000329986CN4 561694CT3 00000329988CN0 912692LS3 00000329989CN8 410604CT 00000329990CN6 469424LS16 00000330531CN5 603332LS16 00000330532CN3 561650CT1 00000330533CN1 865544CT4 00000330698CN2 715847CT3 00000330700CN6 303730CT16 00000330701CN4 217788CT1 00000330703CN0 303PCLS1 00000331097CN6 972731LS16 00000331098CN4 425261CT 00000331099CN2 719560LS16 00000331100CN8 904223CT 00000331101CN6 707423CT1 00000331164CN4 985875LS16 00000331166CN9 RADNETPT1806 00000331756CN7 901523VACT2 00000331757CN5 662326LSCT 00000331759CN1 828894SL16 00000331760CN9 256327PET 00000331763CN3 214648LS16 00000331766CN6 630355LSER16 00000331769CN0 775785CT16 00000331770CN8 941625LS16 00000331771CN6 510307CT1 00000331772CN4 616954CT 00000332077CN7 270444LCT1 00000332078CN5 731425ICT2 00000332079CN3 423559BCT2 00000332080CN1 212230LS16 00000332081CN9 401769WLS 00000332083CN5 352795DLS 00000332084CN3 901726ERCT 00000332709CN5 940384MDCT 00000332733CN5 281FCERACT 00000332734CN3 303433LS16 00000332735CN0 507345CT2 00000332736CN8 206731ERCT 00000332997CN6 212610LS2 00000332998CN4 601815CT1 00000333001CN6 316268CT3 00000333003CN2 803434CT4 00000333005CN7 281341OB16 00000333819CN1 229259LSU2 00000333820CN9 731425CTA 00000333823CN3 330830LS16J 00000333824CN1 732222LS16 00000334464CN5 RADNETCT1483 00000334465CN2 803424CT 00000334467CN8 847490CT16 00000334469CN4 308398CT 00000334899CN2 973625LS16 00000334900CN8 907562PCT3 00000335315CN8 636625SJCT1 00000335316CN6 703670LS16 00000335319CN0 952924CT1 00000335454CN5 409985LS02 00000335455CN2 602824CT16 00000335457CN8 206223MCT3 00000335458CN6 212288CT16 00000335999CN9 816698CPLS 00000336255CN5 702880CT 00000336256CN3 718240LS16 00000336258CN9 727734LS16 00000336260CN5 816276LS16 00000336801CN6 936538PERC 00000336802CN4 303416LS16 00000336804CN0 864560CT2 00000336849CN5 727942LS16 00000336850CN3 704638VACT 00000336852CN9 772335CT1 00000336856CN0 336433DRICT 00000336858CN6 812237CT16 00000337341CN2 409899LS04 00000337343CN8 512OCCT 00000338962CN4 847535LFCT 00000338963CN2 936271EHDLS 00000338967CN3 727869LS16 00000338968CN1 205481CTLS 00000338969CN9 610988CT16 00000338970CN7 INSIGHTPCT1354 00000340316CN9 401845LS 00000340371CN4 303699CT16 00000340372CN2 305666DST 00000340481CN1 336713BCT3 00000340482CN9 509773KCT16 00000340483CN7 615349DST 00000340484CN5 717854CT1 00000341309CN3 513585CT1 00000341310CN1 757466AICTLS 00000341311CN9 757398MVLS 00000341800CN1 228575LS16 00000341885CN2 417269CECT2 00000341886CN0 305285LS 00000342120CN3 740886LS16 00000342461CN1 907861CT16 00000342463CN7 931906CT16 00000342587CN3 207777LS16 00000342588CN1 478765CT 00000342589CN9 417269CECT1 00000342613CN7 423784CT1 00000342624CN4 978458CT2 00000342625CN1 402334L16 00000342626CN9 405752ERCT 00000342627CN7 509575YM16CT 00000342628CN5 773967LS16 00000342630CN1 715526LS16 00000342862CN0 RADNETPT612 00000342863CN8 360256SCT4 00000342864CN6 717337DLS 00000342866CN1 630275GRE16 00000343086CN5 573686LSCT 00000343123CN6 318398CT 00000343125CN1 402746CT 00000343127CN7 330332LS16 00000343230CN9 901726OPCT 00000343231CN7 903315GS16 00000343232CN5 361595SKL1 00000343233CN3 509474SCT 00000343234CN1 801357CT 00000343378CN6 502562LS16 00000343380CN2 303FCBCT1 00000343381CN0 215762LS16 00000343666CN4 817428LS16 00000343667CN2 763509LS 00000343669CN8 865429LS16 00000343670CN6 502629NLS16 00000344109CN4 817551LS16 00000344110CN2 732840LS16 00000344111CN0 203453CT16 00000344528CN5 51024KFCT1 00000344529CN3 918342CRLS 00000344530CN1 509525LSCT 00000344532CN7 614846LS16 00000344962CN6 INSIGHTPCT1356 00000345299CN2 907562DST 00000345444CN4 903439HC16 00000345451CN9 210297SLB16 00000345452CN7 615338PCT 00000345453CN5 858626DST 00000345700CN9 859313CT2 00000345702CN5 RADNETCT1406 00000345975CN7 409838LS16 00000346252CN0 770736CT2 00000346253CN8 423495DST 00000346389CN0 732493LS16 00000346390CN8 913588PETCT 00000346392CN4 SMRDST8 00000346703CN2 316858CT 00000346705CN7 269673CT 00000346744CN6 732390DST 00000346745CN3 FRIORLFRC1 00000346746CN1 479637LS16 00000346882CN4 415641LSGRE 00000346883CN2 281FCLPCT 00000346884CN0 RADNETPT1814 00000347192CN7 478CGDCT16 00000347195CN0 765983CT 00000347362CN6 941795AW 00000347363CN4 386774DST1 00000347365CN9 770736LCT 00000347517CN5 509248VCT16 00000347518CN3 215256CT16 00000347519CN1 704384PHLS 00000347520CN9 817334LS16 00000347755CN1 973754LS2 00000347757CN7 210447FCER16 00000348034CN0 410337LS16 00000348035CN7 864261CT16 00000348036CN5 360413CT2 00000348808CN7 303788DST 00000349095CN0 973972CT2 00000349096CN8 4142814XLS 00000349101CN6 314344DCT 00000349343CN4 281395LS16 00000349344CN2 636947SJCT2 00000349345CN9 605342RCMC 00000349402CN8 515239LS16 00000349403CN6 423844LS16 00000349404CN4 641422CT2 00000349406CN9 985230OPCT 00000350065CN9 352622DLS1 00000350066CN7 816932DLS 00000350067CN5 717270CT2 00000350068CN3 281364CT3 00000350069CN1 512353LS16 00000350423CN0 904824FCT4 00000350424CN8 541440CT 00000350426CN3 281576LS01 00000350494CN1 303695LS16 00000350574CN0 ALLIANCEPCT71 00000350575CN7 504785L16 00000350576CN5 SMSAPL2 00000350577CN3 617632DST 00000351434CN6 662377DISPET 00000351435CN3 586465H16 00000351436CN1 724832DST1 00000351636CN6 845334LS 00000351700CN0 RADNETCT1404 00000351758CN8 916UCDPETCT 00000352578CN9 404778DST 00000352683CN7 1313852 00000352943CN5 713436NPCT 00000353574CN7 478REGCT 00000354237CN0 727446DST 00000354238CN8 205599DST 00000354239CN6 503815CT1 00000354240CN4 214396LS16 00000354677CN7 918744PETCT 00000354890CN6 262363MUK16 00000355816CN0 SMRDST7 00000355968CN9 313593DST 00000355969CN7 602588DST 00000356482CN0 662349CT1 00000356888CN8 847432DST 00000357487CN8 SMRDST5 00000357520CN6 310829DST 00000357521CN4 206223MOB16 00000357522CN2 RADNETPT608 00000357523CN0 432520DST 00000359396CN9 256768EVCT 00000359856CN2 713704DST 00000360319CN8 707442HUMCT 00000360321CN4 206223DST1 00000361546CN5 858569DST 00000361547CN3 941235DST 00000361548CN1 541382PET 00000361549CN9 972899LS16 00000362167CN9 RADNETPT1805 00000362168CN7 205783DST 00000362169CN5 865373CT1 00000362630CN6 215827LS16 00000362633CN0 INSIGHTCT1925 00000362634CN8 570522CT1 00000362635CN5 615320CT 00000364001CN8 845454PCT 00000364002CN6 336716DST1 00000364626CN2 310BHDST 00000365402CN7 732360DST 00000365431CN6 856778DISCST 00000365447CN2 RADNETPT1808 00000366279CN8 760633CT2 00000366341CN6 615884CT1 00000366432CN3 253944CT16 00000366433CN1 417820LSER 00000367476CN9 501922HVCT 00000367929CN7 270926LS16 345974CN0 SHICT69 953828YM1 SHICT19 997216YM7 972549HP60 984695YM7 515247CT5 941025YM9 706922CT 00000404615CN7 806775PETCT 00000941009YM3 713MHDSTM 00000953839YM8 305592LS16 00000953840YM6 406266BHCT1 00000980118YM4 INSIGHTPCT1331 00000984682YM5 615435PCT 00000984689YM0 9167345X 00000984695YM7 515247CT5 00000984696YM5 901726CT2 00000988390YM1 864225CT 00000988401YM6 925933CT3 00000988405YM7 303662CT16 00000988406YM5 440293LS16 00000994073YM5 423622CT 00000994080YM0 407321CFC2 00000994081YM8 901226CT5 00000994082YM6 206386ERCT 00000994085YM9 318442LS16 00000994090YM9 620343CT 00000997213YM4 610325LS16 00000997215YM9 NELCTLS16 00000997220YM9 RADNETCT1401 00001002102YM0 816691PCT16 00001002105YM3 530UCVETCT 00001002108YM7 ALLIANCECT148 00000002993PT4 38852995PETMET
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    Discovery LS, 2286327 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
    GE Medical Systems, LLC
Device Recall GE PET/CT System
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000294153CN2 0910212097 00000309306CN9 0910212101 00000309960CN3 0910212104 00000309960CN3 0910212104 00000311052CN5 0910212105 00000321402CN0 0910212106 00000321402CN0 0910212106 00000337340CN4 0910212115 00000337340CN4 0910212115 00000337340CN4 0910212115 00000297003CN6 0910213064 00000313645CN4 0910213070 00000301209CN3 0910215018 00000313097CN8 0910216036 00000337344CN6 0910216041 00000297460CN8 AH1410CT06 00000325191CN5 AH5362CT02 00000310728CN1 110037CT01 00000310728CN1 110037CT01 00000299935CN7 190020CT03 00000311058CN2 190052CT06 00000297386CN5 190059CT04 00000311058CN2 190052CT06 00000311426CN1 030018CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000327271CN3 10026 00000346702CN4 1350651 00000310682CN0 2850998 00000310682CN0 2850998 00000327815CN7 CT327815CN7 00000332075CN1 BG4037CT01 UNK23399850000 BG4037CT01 00000316663CN4 BG4042CT01 00000316663CN4 BG4042CT01 00000327081CN6 BG4608CT01 00000314635CN4 BG4600CT01 00000357475CN3 CM1007CT02 00000357475CN3 CM1007CT02 00000357475CN3 CM1007CT02 00000361978CN0 082445020003 00000361978CN0 082445020003 00000361978CN0 082445020003 00000352887CN4 082445030003 00000347756CN9 082445100008 00000347756CN9 082445100008 00000309961CN1 082445150001 00000336259CN7 082445150008 00000359854CN7 082445160007 00000354676CN9 082445250002 00000294148CN2 HLGSCTD10002 00000294148CN2 HLGSCTD10002 00000299483CN8 082421111101 00000334898CN4 082421140150 00000322331CN0 082421160145 00000298653CN7 082421030115 00000333002CN4 082421030162 00000295411CN3 082421030340 00000299934CN0 082421040093 00000295644CN9 082421040096 00000299483CN8 082421111101 00000308733CN5 082421040103 00000299951CN4 082421030354 00000299951CN4 082421030354 00000299951CN4 82421030354 00000322333CN6 082421040120 00000295409CN7 082421050034 00000323331CN9 082421050038 00000343124CN4 082421060040 00000317099CN0 082421070116 00000330529CN9 082421070130 00000297900CN3 082421070368 00000323328CN5 082421080059 00000320550CN7 082421100258 00000323310CN3 082421100259 00000322857CN4 082421100260 00000322857CN4 082421100260 00000335318CN2 082421100265 00000336002CN1 082421130067 00000329307CN3 082421160152 00000342614CN5 082421160155 00000295117CN6 082421210084 00000319305CN9 082421220038 00000297900CN3 082421070368 00000331165CN1 082421010103 00000335317CN4 082421010157 00000333000CN8 082421020090 00000287474CN1 082421130055 00000295411CN3 082421030340 00000308614CN7 082421130065 00000336002CN1 082421130067 00000314492CN0 082421140117 00000356887CN0 082421220038 00000336001CN3 082421220044 00000323308CN7 082421020070 00000332999CN2 082421140145 00000295644CN9 082421040096 00000346880CN8 2532905LIG16 00000337342CN0 374521381CT 00000337342CN0 374521381CT 00000295118CN4 DK1018CT01 00000297992CN0 DK1025CT02 00000313915CN1 11390744CT 00000313915CN1 11390744CT 00000323858CN1 FI1003CT03 00000295643CN1 FI1017CT02 00000323858CN1 FI1003CT03 00000295643CN1 FI1017CT02 00000304685CN1 A4167313 00000319308CN3 B4195716 00000313650CN4 C6010809 UNK23399850001 GOLD001266 00000298318CN7 GOLD010093 00000310120CN1 X966077004 00000313650CN4 C6010809 00000324460CN5 M1020808 00000326112CN0 M1279722 00000311808CN0 M2312304 00000293009CN7 M2322212 00000307022CN4 M23737001 00000311059CN0 M2486504 00000305523CN3 M2800910 00000317193CN1 M2848414 00000298344CN3 M40345153 00000298327CN8 M4047054 00000298318CN7 GOLD010093 00000320672CN9 M4160064 00000303583CN9 M4163021 00000324985CN1 M4174504 00000298659CN4 M4180123 00000310268CN8 M4191025 00000326084CN1 M4192518 00000325672CN4 M4198036 00000326326CN6 M4198185 00000304683CN6 M4215536 00000336000CN5 M4409416 00000336003CN9 M4491526 00000309305CN1 M4491923 00000319062CN6 M4497247 00000302751CN3 M4516011 00000293499CN0 M5481223 00000315232CN9 M5647104 00000326111CN2 M8050904 00000296278CN5 M9202219 00000297389CN9 M9481828 00000297389CN9 M9481828 00000315232CN9 M5647104 00000305523CN3 M2800910 00000297001CN0 270494CT02 00000310266CN2 X751962001 00000311422CN0 X90281601 00000318593CN1 X965468001 00000319063CN4 X976365001 00000322856CN6 X98683601 00000329304CN0 X993729001 00000336000CN5 M4409416 00000325672CN4 M4198036 00000304683CN6 M4215536 00000298327CN8 M4047054 00000311059CN0 M2486504 00000336000CN5 M4409416 00000329304CN0 X993729001 00000319063CN4 X976365001 00000309305CN1 M4491923 00000317193CN1 M2848414 00000307022CN4 M23737001 00000324985CN1 M4174504 00000319062CN6 M4497247 00000298659CN4 M4180123 00000311422CN0 X90281601 00000326111CN2 M8050904 00000319062CN6 M4497247 00000319062CN6 M4497247 00000311059CN0 M2486504 00000298327CN8 M4047054 00000307022CN4 M23737001 00000304683CN6 M4215536 00000324985CN1 M4174504 00000304683CN6 M4215536 00000329303CN2 GOLD010082 00000329303CN2 GOLD010082 00000329303CN2 GOLD010082 00000309522CN1 GOLD001588 00000297427CN7 GOLD001604 00000293010CN5 GOLD002151 00000319948CN6 GOLD002182 00000293010CN5 GOLD002151 00000297427CN7 GOLD001604 00000319948CN6 GOLD002182 00000309522CN1 GOLD001588 00000296977CN2 410014CT01 00000288652CN1 CC0618CT02 00000313361CN8 HC0399CT01 00000301205CN1 HC1627CT04 00000310261CN3 HC2252CT01 00000294145CN8 HC3076CT01 00000302750CN5 HC3314CT02 00000327818CN1 HC4438CT01 00000311056CN6 PC1268CT03 00000317102CN2 PC1401CT01 00000302754CN7 PC7479CT02 00000299235CN2 PC8118CT03 00000294146CN6 UC1590CT01 00000296977CN2 410014CT01 00000310261CN3 HC2252CT01 00000294146CN6 UC1590CT01 00000302754CN7 PC7479CT02 00000309302CN8 HC3428CT02 00000310261CN3 HC2252CT01 00000302754CN7 PC7479CT02 00000305953CN2 05252CTS01 00000305953CN2 05252CTS01 00000294146CN6 UC1590CT01 00000327079CN0 GP1036CT01 00000297599CN3 0828210042 00000309521CN3 0828210045 00000322338CN5 0828210046 00000330530CN7 0828210047 00000323258CN4 0828210094 00000323258CN4 0828210094 00000325192CN3 HU1137CT02 00000319061CN8 Unlocated 00000317789CN6 GOLD010275 00000313648CN8 HU1008CT02 00000297465CN7 HU1039CT03 00000297465CN7 HU1039CT03 00000300567CN5 083021840009012 00000331758CN3 08302100210134X 00000342119CN5 083021042101703 00000345300CN8 083021242100044 00000307945CN6 083021592012120 00000332732CN7 083021602101433 00000311812CN2 083021802100123 00000331758CN3 08302100210134X 00000336854CN5 083021824542213 00000322337CN7 083021842100841 00000336854CN5 083021824542213 00000333821CN7 IR1050CT02 00000330534CN9 IL1000CT01 00000314489CN6 A5816714 00000298365CN8 A206873404 00000294150CN8 A224457303 00000314489CN6 A5816714 00000298364CN1 A5109820 00000329300CN8 A5114983 UNK23399850002 A5127399 00000297387CN3 A5158020 00000298788CN1 A5248810 00000297006CN9 A5279809 00000297467CN3 A5315535 00000305241CN2 A5333021 00000325670CN8 A5364424 00000318594CN9 A5366613 00000297991CN2 A5375119 00000297991CN2 A5375119 00000298788CN1 A5248810 00000308141CN1 A5630204 00000314489CN6 A5816714 00000296974CN9 A5824009 00000316659CN2 A95819201 00000297991CN2 A5375119 00000308982CN8 QW2001 00000294505CN3 QW2006 00000295885CN8 QW2007 00000294505CN3 QW2006 00000304155CN5 QW2021 00000304690CN1 QW2023 00000304692CN7 QW2024 00000305242CN0 QW2025 00000307953CN0 QW2026 00000305954CN0 QW2027 00000305522CN5 QW2028 00000310727CN3 QW3032 00000303514CN4 QW3033 00000311054CN1 QW3036 00000304691CN9 QW3037 00000310876CN8 QW3039 00000303582CN1 QW3040 00000313918CN5 QW3042 00000317976CN9 QW3044 00000309301CN0 QW3045 00000314632CN1 QW3052 00000324987CN7 QW3054 00000325671CN6 QW3055 00000320665CN3 QW3058 00000331765CN8 QW3070 00000304158CN9 QY0002 00000297463CN2 QY0006 00000310122CN7 QY0058 00000313651CN2 QZ0064 00000352579CN7 YE0201 00000357355CN7 YE0202 00000361979CN8 YE0203 00000354674CN4 YE0205 00000365101CN5 YE0210 00000366340CN8 YE0211 00000348807CN9 YE0214 00000293890CN0 QW2002 00000292947CN9 QW2004 00000294768CN7 QW2005 00000298654CN5 QW2009 00000297005CN1 QW2010 00000299761CN7 QW2012 00000298655CN2 QW2013 00000301085CN7 QW2014 00000301207CN7 QW2015 00000295646CN4 QW2018 00000299762CN5 QW2019 00000301206CN9 QW2022 00000310264CN7 QW2029 00000307949CN8 QW3031 00000313364CN2 QW3041 00000297007CN7 QW3043 00000322855CN8 QW3047 00000326660CN8 QW3047 00000321451CN7 QW3048 00000322120CN7 QW3048 00000326662CN4 QW3053 00000297005CN1 QW2010 00000298361CN7 QX0014 00000297007CN7 QW3043 00000297007CN7 QW3043 00000303436CN0 QY0017 00000296978CN0 QY0044 00000301211CN9 QZ0006 00000298785CN7 QZ0008 00000294147CN4 QZ0009 00000293891CN8 QZ0036 00000295415CN4 QZ0039 00000297597CN7 SG0033 00000292948CN7 XG0009 00000354889CN8 YE0204 00000305243CN8 QW3034 00000305243CN8 QW3034 00000348807CN9 YE0214 00000311418CN8 JO1000CT02 00000298652CN9 JO1009CT03 00000298652CN9 JO1009CT03 00000307946CN4 ZA6002CT02 00000295412CN1 0850210523X 00000295413CN9 0850210532 00000309310CN1 0850210548X 00000314641CN2 0850210549 00000323317CN8 0850210550X 00000329993CN0 0850210825 00000329305CN7 0850210552 00000335459CN4 0850210554 00000332082CN7 0850210555 00000334466CN0 0850210873 00000334880CN2 0850210557 00000336853CN7 0850210558X 00000336257CN1 0850210837 00000329993CN0 0850210825 00000336257CN1 0850210837 00000334466CN0 0850210873 00000322332CN8 KW1012CT02 00000321964CN9 LB1050CT01 00000309523CN9 110807CT01 00000294851CN1 0834210019 00000294851CN1 0834210019 00000294502CN0 CT294502CN0 00000346391CN6 2535997DST 00000346391CN6 2535997DST 00000359395CN1 2546945DST 00000295414CN7 73801LS16S 00000294502CN0 CT294502CN0 00000294502CN0 CT294502CN0 00000307947CN2 NO1052CT02 00000293035CN2 OM1043CT01 00000293035CN2 OM1043CT01 00000297995CN3 0843210037 00000301208CN5 0843210038 00000343087CN3 0843210116 00000343087CN3 0843210116 00000298359CN1 600042CT01 00000305951CN6 600062CT01 00000298359CN1 600042CT01 00000305951CN6 600062CT01 00000314495CN3 PPR56604 00000314495CN3 PPR56604 00000314495CN3 PPR56604 00000314493CN8 809780LS16 00000310681CN2 809740LS16 00000297897CN1 RE1001CT02 00000297897CN1 RE1001CT02 00000328357CN9 RU2116CT01 00000296276CN9 SA1011CT02 00000328360CN3 SA1012CT08 00000328359CN5 SA1007CT03 00000317094CN1 SA1014CT02 00000310875CN0 SA1279CT01 00000001380806 0847210020 00000001380806 0847210020 00000303589CN6 SK1003CT01 00000327082CN4 SK1056CT01 00000323315CN2 ZA1000CT02 00000323315CN2 ZA1000CT02 00000310270CN4 ZA1247CT01 00000318926CN3 ZA1442CT02 00000314636CN2 ZA2103CT01 00000314636CN2 ZA2103CT01 00000295879CN1 UPW00600 00000308732CN7 082421160123 00000329306CN5 DE188430 00000327272CN1 DEL26410 00000329991CN4 DEL89957 00000329991CN4 DEL89957 00000309308CN5 DEN27243 00000297385CN7 DPB15832 00000293038CN6 DPC32410 00000030411CN8 DPM32132 00000313369CN1 DPM99916 00000297902CN9 FPG03601 00000305945CN8 FPG03720 00000304109CN2 FPG08400 00000305945CN8 FPG03720 00000330699CN0 FPG79903 00000310874CN3 MPX02003 00000329992CN2 NP739714 00000294144CN1 NPV13924 00000310874CN3 MPX02003 00000294144CN1 NPV13924 00000294144CN1 NPV13924 00000297902CN9 FPG03601 00000295879CN1 UPW00600 00000313369CN1 DPM99916 00000304109CN2 FPG08400 00000293038CN6 DPC32410 00000304109CN2 FPG08400 00000295879CN1 UPW00600 00000293038CN6 DPC32410 00000297902CN9 FPG03601 00000313369CN1 DPM99916 00000299766CN6 A010CT07 00000311423CN8 A010CT08 00000325188CN1 A010CT09 00000354675CN1 C011PE01 00000323859CN9 259130CT02 00000297002CN8 260010CT13 00000297002CN8 260010CT13 00000304112CN6 426020CT02 00000323859CN9 259130CT02 00000323859CN9 259130CT02 00000296274CN4 501030CT02 00000297466CN5 529040CT01 00000296274CN4 501030CT02 00000313362CN6 899010CT02 00000346701CN6 900010PE08 00000297002CN8 260010CT13 00000346701CN6 900010PE08 00000296274CN4 501030CT02 00000304112CN6 426020CT02 00000304112CN6 426020CT02 00000299949CN8 0853210138 00000312925CN1 0853210142 00000312925CN1 0853210142 00000318883CN6 0853210145 00000318883CN6 0853210145 00000328912CN1 0853210150 00000338965CN7 0853450020 00000346743CN8 0853450023 00000354795CN7 0853450038 00000354795CN7 0853450038 00000359858CN8 0853450062 00000298792CN3 TN1013CT03 00000298319CN5 TN1006CT03 00000294852CN9 TN1168CT01 00000310879CN2 AE1005CT02 00000310879CN2 AE1005CT02 00000305239CN6 05006CTS01 00000307948CN0 05027CTS03 00000305953CN2 05252CTS01 00000293032CN9 00243CTS05 00000293032CN9 00243CTS05 00000294856CN0 00361CTS02 00000318595CN6 00537CTS01 00000294042CN7 00557CTS01 00000305952CN4 01051CTS02 00000293032CN9 00243CTS05 00000300489CN2 00020CTS01 00000299314CN5 00095CTS01 00000312924CN4 00160CTS02 00000311813CN0 00257CTS02 00000314497CN9 10079CTM62 00000294343CN9 10441CTS01 00000312815CN4 10458CTS01 00000311420CN4 70050CTS02 00000313653CN8 70328CTS03 00000310732CN3 80040CTS02 00000322119CN9 01027CTS01 00000323259CN2 00432CTS03 00000295880CN9 00298CTS07 00000305524CN1 00216CTS04 00000298358CN3 00133CTS02 00000310262CN1 PM1633CT04 00000311810CN6 763588SPCT 00000336801CN6 936538PERC 00000316259CN1 210351MSDLS 00000328245CN6 706378LS16 00000304684CN4 714633CTM 00000294765CN3 251368ACT 00000316660CN0 402887CT16 00000293034CN5 419584CT 00000318591CN5 309680CT 00000317568CN4 214647LS16 00000336801CN6 936538PERC 00000318591CN5 309680CT 00000316660CN0 402887CT16 00000293034CN5 419584CT 00000317568CN4 214647LS16 00000294765CN3 251368ACT 00000316259CN1 210351MSDLS 00000311810CN6 763588SPCT 00000328245CN6 706378LS16 00000294345CN4 SMGCT15 00000296976CN4 38826196CTOCC 00000296976CN4 38826196CTOCC  00000323258CN #N/A
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    Discovery ST, , 2339985 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
    GE Medical Systems, LLC
Device Recall GE PET/CT System
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000350495CN8 A5333025 00001001853YM9 AL4004CT01 00000953838YM0 AL4023CT01 00001001879YM4 0002876927 00000357924CN0 1577LS16 00001001879YM4 0002876927 00001001879YM4 0002876927 00001001879YM4 0002876927 00001010424YM8 0910212127 00001010461YM0 0910212129 00001010461YM0 0910212129 00001010471YM9 0910213084 00000980093YM9 0910212119 00000980093YM9 0910212119 00000994084YM2 0910212123X 00000984698YM1 0910213080 00001010387YM7 0910215023 00001010475YM0 0910215025 00001001897YM6 AH5703CT01 00000980120YM0 AH4001PE01 00000988410YM7 110002CT02 00000953828YM1 110017CT01 00000980106YM9 110040CT03 00000953853YM9 110059CT01 00000988410YM7 110002CT02 00000980111YM9 030355CT03 00000980111YM9 030355CT03 00001002103YM8 2858149 00000383739CN0 CT383739CN0 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00001002107YM9 082421120191 00000364134CN7 082445160009 00000365398CN7 082445040002 00000363607CN3 082421100316 00001002106YM1 082421110048 00000953856YM2 082421120171 00001001852YM1 082421120187 00001010423YM0 082421100294 00001010444YM6 082421100301 00000941008YM5 082421020154 00000988393YM5 082421030172 00000996079YM0 082421030175 00000988398YM4 082421050047 00000996082YM4 082421100157 00000984688YM2 082421100270 00000988395YM0 082421100276 00000988397YM6 082421100278 00000984685YM8 082421100283 00001010426YM3 082421160169 00001010436YM2 082421160176 00000980095YM4 082421180052 00001010457YM8 082421180061 00001023062YM1 082421180064 00000984699YM9 082421010160 00000941008YM5 082421020154 00000994089YM1 082421100284 00001002104YM6 082421120188 00000984700YM5 082421130071 00000988386YM9 082421130073 00001010451YM1 082421100307 00001010455YM2 082421290042 00001010478YM4 EE1020CT01 00001010478YM4 EE1020CT01 00000953833YM1 FI1052CT02 00000994076YM8 A9885025 00000994074YM3 C2195260 00000994074YM3 C2195260 00000994076YM8 A9885025 00000994086YM7 GOLD010094 00000363551CN3 X265413001 00000988394YM3 M1612804 00000984701YM3 M2311502 00000994086YM7 GOLD010094 00001023052YM2 M4162509 00000953834YM9 M4189251 00000953830YM7 M4217029 00000953837YM2 M4400629 00001001899YM2 M4480007 00000980112YM7 M4490502 00000980094YM7 M4505261 00000997212YM6 M4854012 00001001883YM6 M6065310 00000994076YM8 A9885025 00000941016YM8 X100719101 00001023052YM2 M4162509 00000363551CN3 X265413001 00000365551CN3 X265413001 00001023056YM3 X706835004 00000363551CN3 X265413001 00000363551CN3 X265413001 00000984701YM3 M2311502 00000988394YM3 M1612804 00000997212YM6 M4854012 00001001883YM6 M6065310 00000994074YM3 C2195260 00000984701YM3 M2311502 00000997212YM6 M4854012 00001023052YM2 M4162509 00001001883YM6 M6065310 00000980117YM6 GOLD010585 00000980117YM6 GOLD010585 00001001860YM4 420127CT01 00001010403YM2 439532CT01 00001023050YM6 442365CT01 00000980113YM5 PROS01CT04 00001023051YM4 UHAN01CT07 00000980113YM5 PROS01CT04 00000980113YM5 PROS01CT04 00000988408YM1 393115CT01 00000953843YM0 408749CT01 UNK2378661-305 439532CT01 UNK23786610001 CC4821CT03 00000941024YM2 HC1649CT01 00000953843YM0 408749CT01 00000988384YM4 HC4912CT01 00000988382YM8 HC4912CT02 00000953855YM4 HC7946CT03 UNK23786610000 HC7946CT03 UNK2378661-305 439532CT01 00000988382YM8 HC4912CT02 00001001866YM1 PC0075CT05 00000988385YM1 PC0815CT05 UNK2378661-300 PC4176CT02 00000941022YM6 PSTU02CT06 00000953843YM0 408749CT01 00000980105YM1 UC1923CT05 00000941024YM2 HC1649CT01 00000980105YM1 UC1923CT05 00000941022YM6 PSTU02CT06 00000953855YM4 HC7946CT03 00000988384YM4 HC4912CT01 00001001878YM6 00257CTS04 00000953843YM0 408749CT01 00000953843YM0 408749CT01 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001886YM9 H2094CT11 00001023049YM8 H2112CT02 00000984691YM6 H5826CT01 00001010448YM7 0828210052 00001023047YM2 HU1114CT01 00000988402YM4 083021061102211 00001010441YM2 083021602200264 00000408732CN6 0002777955 00000408732CN6 0002777955 00000341516CN3 IL1020NM31 00000980121YM8 IL1082CT02 00000341516CN3 IL1020NM31 00000341516CT3 IL1082CT03 00001001875YM2 A5348207 00000994075YM0 A5258505 00000941013YM5 A257527001 UNK2378661-302 A5111130 00001010481YM8 A5118059 00000996077YM4 A5124913 00001001869YM5 A5128405 00000364957CN1 A5129956 00001001869YM5 A5128405 00001010476YM8 A5311007 00001023057YM1 A5379305 00001010440YM4 A5387105 00001001874YM5 A5618325 00001010473YM5 D5249901 00000953846YM3 A224857323 00000980115YM0 A5110016 UNK2378661-303 A5127399 00000984684YM1 A5131848 00000941018YM4 A5144908 00000953852YM1 A5164340 00000980115YM0 A5110016 00000364182CN6 A5215931 00000984692YM4 A5358103 00000988388YM5 A5361302 00000980116YM8 A5413819 00000980115YM0 A5110016 UNK2378661-304 B5343102 00000980114YM3 H5382003 00000941036YM6 QT3029 00000941014YM3 QT3030 00000941031YM7 QT3031 00000941033YM3 QT3032 00000953829YM9 QT3033 00000953850YM5 QT3034 00000953847YM1 QT3036 00000980100YM2 QT3037 00000980098YM8 QT3039 00000980096YM2 QT4049 00000980101YM0 QT4050 00000994079YM2 QT4051 00001001854YM7 QT4056 00001001855YM4 QT4057 00001010392YM7 QT4061 00000996072YM5 QT4062 00001010401YM6 QT4063 00001023043YM1 QT4065 00001023042YM3 QT4066 00001010416YM4 QT4077 00000953831YM5 QW3056 00000953849YM7 QW3057 00000980097YM0 QW3059 00000988399YM2 QW3064 00001001857YM0 QW3068 00001023044YM9 QW4087 00000953849YM7 QW3057 0000000G16ME01 QX0044 00000953827YM3 QY0012 00000980099YM6 QZ0001 00000941032YM5 QZ0021 00001023046YM4 SG0090 00000941035YM8 XF0010 00000941010YM1 XF0018 00000941025YM9 QT3027 00000941030YM9 QT3028 00000953832YM3 QT3035 00001023058YM9 QT3035 00000980103YM6 QT3040 00000980102YM8 QT3041 00000980107YM7 QT3042 00000941034YM1 QT3044 00000984686YM6 QT3045 00000984697YM3 QT3047 00000988400YM8 QT3048 00000996076YM6 QT4052 00000980110YM1 QT4054 00001001856YM2 QT4055 00001001895YM0 QT4058 00000988389YM3 QT4060 00001010452YM9 QT4064 00001023045YM6 QT4074 00001010449YM5 QV0030 00000941026YM7 QW3051 00000941028YM3 QW3060 00000941020YM0 QW3077 00000941023YM4 QW3078 00000988392YM7 QW3080 00001010453YM7 QW4088 00000988409YM9 QY0014 00000996073YM3 QY0041 00000980119YM2 QZ0020 00000941012YM7 XF0022 00000988404YM0 XF0149 00001010437YM0 0850210570 00001010439YM6 0850210572 00000984687YM4 0850210560 00000994072YM7 0850210562 00000941017YM6 KW1042CT01 00001023064YM7 KW1008CT03 00000941027YM5 KW1013CT01 00000941017YM6 KW1042CT01 00000941017YM6 KW1042CT01 00001010472YM7 LB1160CT01 00001010472YM7 LB1160CT01 00001010472YM7 LB1160CT01 00000953854YM7 LY1018CT01 00001010454YM5 0834210024 00001010454YM5 0834210024 00000354679KN3 314LS2543020 00001001867YM9 449CT2893654 00000361838CN6 44LS2551149 00000365448CN0 57CTLS16 00000953851YM3 MA1013CT02 UNK2378661-301 DVT0122 00001010463YM6 0920219033 00000361714CN9 0843210103 00001010432YM1 PL1019CT02 00001001885YM1 PL1235CT03 00001001885YM1 PL1235CT03 00001010460YM2 RU1078CT02 00001023060YM5 RU2526CT01 00001001898YM4 RU2705CT01 00000994077YM6 RU1158CT01 00001023065YM4 SA1387CT01 00000984683YM3 0847210020 00001001893YM5 ZA1071CT01 00000994088YM3 ZA1127CT02 00000994088YM3 ZA1127CT02 00001010442YM0 ZA2051CT01 00001023048YM0 ZA2244CT01 00001001891YM9 EPI28404 00000996081YM6 FPA99409 00001010462YM8 YP308712 00001010419YM8 082421140154 00001001858YM8 MPX30218 00001010446YM1 C003CT01 00001023063YM9 L006CT01 00000984694YM0 475230CT04 00000988396YM8 529170CT05 00000988396YM8 529170CT05 00000988396YM8 529170CT05 00000994078YM4 0853210154 00001010465YM1 01017CTS01 00001001892YM7 06013CTS01 00000953842YM2 38006CTS01 00001010406YM5 UK1085CT01 00000988387YM7 AE1021CT02 00001001878YM6 00257CTS04 00000980109YM3 00416CTS03 00000941019YM2 00432CTS03 00000953844YM8 00468CTS01 00000984693YM2 00664CTS02 00001001873YM7 01211CTS02 00001001872YM9 70365CTS03 00001001887YM7 00094CTS01 00000953835YM6 10470CTS01 00000953845YM5 10476CTS01 00000953848YM9 10479CTS01 00000988403YM2 10486CTS01 00001001896YM8 77266CTS02 00001001896YM8 77266CTS02 00000953841YM4 00314CTS02 00001010390YM1 941747LS16 00001010390YM1 941747LS16 00001010474YM3 928669CT 00001001861YM2 770638LS16 00001001861YM2 770638LS16 00000344959CN2 ZWL0470
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    LightSpeed 16 (MDAS only || , , 2339985 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
    GE Medical Systems, LLC
Device Recall GE PET/CT System
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000002493PT5 0850450029
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    LightSpeed Plus (4-slice MDAS || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
    GE Medical Systems, LLC
Device Recall GE PET/CT System
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000006841PT1 PET368725CN8 00000004411PT5 4512-1 00000004411PT5 4512-1 00000006841PT1 PET368725CN8 00000005376PT9 PET357769CN9 00000005670PT5 082426140014 00000006610PT0 082445020003 00000006610PT0 082445020003 00000006610PT0 082445020003 00000006119PT2 082445030003 00000005815PT6 082445050003 00000006146PT5 082445090002 00000005808PT1 082445100008 00000006177PT0 082445100009 00000006175PT4 082445130004 00000005670PT5 082426140014 00000005808PT1 082445100008 00000006500PT3 082445160007 00000006242PT2 082445190002 00000006200PT0 082445250002 00000005251PT4 H4858964 00000005121PT9 M4143813 00000005352PT0 M4144860 00000005323PT1 X105967801 00000006194PT5 HU1167PT01 00000006762PT9 0004168403 00000006762PT9 0004168403 00000005809PT9 IE1005PT01 00000004588PT0 IL1062NM18 00000006120PT0 A5107746 UNK51012720002 A5107746 UNK51012720001 A5215931 00000006003PT8 A5333025 00000004619PT3 A99263301 00000006292PT7 YD0024 00000006293PT5 YD0025 00000006039PT2 YE0001 00000006273PT7 YE0002 00000006272PT9 YE0003 00000006345PT3 YE0004 00000006346PT1 YE0005 00000006808PT0 YE0006 00000006488PT1 YE0007 00000006403PT0 YE0008 00000006368PT5 YE0011 00000006274PT5 YE0077 00000005920PT4 YE0101 00000006141PT6 YE0102 00000006076PT4 YE0103 00000006404PT8 YE0104 00000006496PT4 YE0105 00000006405PT5 YE0106 00000006453PT5 YE0107 00000006636PT5 YE0108 00000006331PT3 YE0110 00000006347PT9 YE0111 00000006454PT3 YE0112 00000006115PT0 YE0201 00000006407PT1 YE0202 00000006611PT8 YE0203 00000006245PT5 YE0205 00000006810PT6 YE0210 00000006843PT7 YE0211 00000005813PT1 YE0214 00000006367PT7 YE0109 00000006304PT0 YE0204 00000005813PT1 YE0214 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004463PT6 0850450055 00000005495PT7 0850450056X1 00000005342PT1 0850450057 00000005342PT1 0850450057 00000005878PT4 0850450058 00000006176PT2 0850450059 00000006176PT2 0850450059 00000005785PT1 0834450001 00000005785PT1 0834450001 00000005719PT0 2535997DST 00000005719PT0 2535997DST 00000006486PT5 2546945DST 00000006148PT1 FE816135 UNK51012720004 FE816135 00000004732PT4 FEG81300 00000006302PT4 NP739714 UNK51012720000 Not Available 00000006201PT8 C001PE03 00000006201PT8 C001PE03 00000006294PT3 259130PE01 00000006294PT3 259130PE01 00000005184PT7 0853450020 00000004676PT3 0853450021 00000005784PT4 0853450023 00000005880PT0 0853450026 00000006244PT8 0853450038 00000006244PT8 0853450038 00000006501PT1 0853450062 00000004624PT3 06008PET01 00000005169PT8 01293DST01 UNK51012720003 10495DST01 00000005892PT5 561883DST 00000006457PT6 388559737PETMET
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    LightSpeed QX/I (4-slice MDAS) || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
    GE Medical Systems, LLC