GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS, H2400YJ, H2400YK. Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

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

Lote

15012 919684INF1 16089 319356INF 16168 801562JVH02 16074 519749INFINIA2 16061 82426040033 16076 82426040030 16085 82426310015 16158 DK1029NM05 16067 FI1023MN02 16068 FI1153MN01 16141 A5152964 16056 NO1088MN09 16152 00053NUC06 16001 906776INF 16005 615768SCNM1 16015 717782INF 16018 907562NM1 16033 318681INFINIA 16036 920738INF 16043 210921NM1 16045 941637INF 16051 507345INF1 16054 630801INF 16065 860350INIF 16071 763UNTYINFI 16075 937328INF2 16083 973625INFINIA 16084 518828INF 16088 908522INFINIA 16098 203325INF2 16111 956350NM1 16118 814533INF 16123 716366INF 16162 704783INFI3 16166 717627INFINIA 16436 203325INF 16140 110034NU04 16022 905372INFINIA 16039 905731INFINIA 16044 519749INFINIA 16072 450654INF2 16016 M2269829 16092 V2728105 16114 S4160059 16079 783348NU01 16017 HU1039NM02 16126 83026602101643 16135 A5172907 16142 A5197927 16115 850260061 16130 850260060 16170 850260063 18130 2919654INF 16019 MA1154NM02 16106 O005NU14 16049 45001NUC01 16004 00216NUC11 1505 508427INFINIA 10548 608263INF 15010 727461VG 15013 661633NM1 16006 310543INF1 16007 619482INFINIA 16008 509474INFINIA 16009 434924INF2 16010 605333INFINIA 16013 303320IH 16020 775423INF1 16021 928537INF 16026 941629INF 16028 434924INF1 16029 408259IN1 16030 626570INF1 16035 907562NM2 16037 713785SLINF1 16038 LGMCINF2 16046 757668INF1 16050 989723INF1 16052 206223INF 16055 215952INF 16059 916983INFN1 16062 937328INF1 16069 715839INF 16070 225765INF1 16073 989723INF2 16082 516570INF 16109 920684INF 16110 408559IN1 16112 801584INF1 16121 801584INF2 16124 704384HAWK1 16151 603650INFINIA1 16159 937208INF1 16163 615322NM3 16169 858554INF1 16171 409727NM1 16173 508828INF 16097 910266042 16122 910266045 16133 910263135 15006 130139NU02 16040 030209NU02 16128 110022NU03 16027 519752INFINIA 16060 450654INF1 16153 604278INFINIA1 16154 604875INFINIA2H 16138 82426090016 16172 82426160026 16174 82426310025 16024 82426200003 16014 C4191749 16023 M2846905 16101 V8572204 16146 828260005 16066 83026805120043 DUMFMI40849012 IL1020NM25 16148 A5109126 16149 A5115111 16119 HGL0233 16156 ALM0131 16078 NO1016MN16 16103 809758INFINIA 16053 DPN00002 16057 856260023 16120 77137NUC01 16125 00109NUC04 16127 01243NUC02 16131 00361NUC05 16132 01367NUC01 16164 00130NUC03 16120 00137NUC01 16048 316962WI 16058 763MRCYINFI 16081 414384INF 16099 919934INF 16155 585922INF1 16175 626359INF2 16177 626359INF1 16180 504873INF 16182 863687INF1 16184 937208INF2 16185 863687INF2 16186 858554INF2 16189 704384INFI2 16194 704783INFI2 16196 704783INFI1 16208 865947INFINIA1 16209 904821NM1 16212 843724INF 16221 781979INF1 16223 623478NM2 16227 214820INF1 16228 904821NM2 16229 717544INFINIA 16234 601978INF 16235 865545INFINIA1 16239 702369NM 16259 601376INF1 16262 404712INF 16269 262363INF 16271 903731INFINIA 16285 573686INF1 16286 828286INFINIA 16301 937278INF 16303 502868INF1 16305 941235INF 16312 432685DNUC 16319 708747INFACQ 16322 845987INFINIA 16326 941766INF2 16344 517543INF 16354 319768INF 16356 419483NUC2 16372 713359INF1 16378 847535INFACQ 16382 252436INF1 16408 906293INF 16410 ARHINFI 16411 812522INF 16412 352333INF 16413 228436INF 16415 773665INF2 16418 773665INF1 16421 LGMCINF 16422 812485INF 16425 607737INF 16426 610770INFINIA 16429 828696INFINIA1 16437 415222IN1 16441 801357INF1 16442 601936INF1 16443 305835INF 16454 443481INF 16456 804594INF1 16457 845783ORA01 16464 210705NM1 16465 615284INF1 16466 843724INF2 16470 630856INF 16474 417256INF 16475 504873INF2 16475 504380INF 16477 502259INF 16479 843431IN 16489 732292INFINIA 16491 301877INF 16494 479463INF 16497 248898INF 16499 615342INF1 16528 225381INF 16534 319768INF2 16539 214879INF 16541 951696INF1 16542 630275INF 16548 702388VNM 16553 630545INF 16557 215537INFINIA 16559 302428INF 16560 704739INFI 16564 501202INF 16566 405610MINF1

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States