Retiro De Equipo (Recall) de Device Recall GE PET/CT System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Medical Systems, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    73248
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1049-2016
  • Fecha de inicio del evento
    2016-02-10
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, tomography, computed, emission - Product Code KPS
  • Causa
    Ge healthcare has updated the service manuals for a number of ct and pet ct scanners to update an incorrect torque value.
  • Acción
    GE Healthcare sent an Urgent Medical Device Correction letter " GEHC Ref# 25467-ABT or 25467" dated February 12, 2016, to all affected consignees . The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology, & Radiologist/Cardiologist. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees were instructed to ensure that the organization that service their equipment uses the latest version of the Service Manual to maintain the safe and proper performance of their medical device. For questions call in the United States: 1-800-437-1171 or your local GE Healthcare Service Representative. For questions regarding this recall call 262-513-4122.

Device

  • Modelo / Serial
    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 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  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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 .
  • Descripción del producto
    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

Manufacturer

  • Dirección del fabricante
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA