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

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 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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 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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 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ALLIANCECT148 00000002993PT4 38852995PETMET

Radiology Devices

2

No

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 .

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.