GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion). The GE Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to produce additional images, imaging planes, and analysis results. The system may be used for patients of all ages. The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages. - The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scann

Recall details

Manufacturer

GE Healthcare, LLC

Distributor

Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MI, ME, MD, MA, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WV and WI., and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY,. JAPAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, NETHERLANDS, NEW ZEAL NAD, NORWAY, PAKISTAN, POLAND,QUATAR, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN,K THAILAND, TURKEY and UNITED KINGDOM.

Lot

Serial # System ID 21000 262574D670 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21054 262574D630 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21111 DUKECCDSV670NM 21114 614NCH670 21117 262574O640 21127 410D6701 21149 540332D670 21157 856247D670 21172 630432D670 21182 GON1409671 21188 415353D670 21189 DUKEDMP670NM 21193 610402D670NM1 21201 720848D670 21202 972747NM670 21221 410955D670 21223 307362D670 21224 660890D670 22002 619474D630 22004 618443DISC1 22007 814623D630 22010 251639D630 22012 704355D630 22013 956523D630 22017 845454D630 22018 618842DISC1 22024 601354D630 22025 773282D630 22026 813558D630 22027 941LWRNM630 22029 PRINCE630 22030 281540D630 22032 417781D630 22033 601288D630 22034 913345D630 22036 318798D630 22039 614NCH630 22040 904321DSC1 22041 317887D630 22042 318448D630 22043 JHDSV630NM 22045 217544PH630 22046 301877D630 22047 601798D630 22048 716372NM630 22049 580531NM630 22050 651DSC630 22052 205333D630 22053 618942NM630 22054 813615D630 22055 719587D630 22056 903GSD630 22057 417533D630 22058 708684D630 22059 937SNHC630 22060 GON1399460 22061 GON1399458 22062 GON1399459 22063 GON2996508 22064 918502DIS1 22065 804675D630A 22066 469814NM630 22067 978354DSV630 22068 585922NM630 22069 305596D630A 22070 GON4029581 22072 POIN630 22076 GON1406902 22077 816234D630 22081 808485NM630 22082 989227D630 22085 305596D630B 22087 801714D630 22088 815564D630 22090 GON1413295 22091 702388VNM2 22092 760778D630 22094 269945D630 22095 843347D630 22096 201418D630 22097 319364D630B 22098 207664NM630 22099 334287NM630 22101 609978D630 22103 843797TD630 22105 319364D630A 22112 OSC630 22117 330386D630 22119 909599D630 22122 904276DSC1 22123 270417D630 22124 901226D630 22125 208455NM630 22126 409212NM630 22127 770751D630 22131 DMP630A 22132 936NMD630 22134 856355D630 22135 DMP630B 22136 605322D630 22137 775STMANM630A 22138 951303D630 22139 850862D630 22141 765447D630 22143 203384D630 22144 WH231NM630 22145 603354NM630 22148 302430NUC630 24001 406222LN615 24003 478272NM 24004 GON1399612 24006 806665NM615 24013 702304NM615 25004 GON1407649 25012 GON1415326 25018 816234D640 25026 928214NMCT 26004 815564O640 26007 817250NM640 26010 717782640NM 26011 GON1415328 26012 808485NM640 26013 847872O640 26014 901516GO640 26018 270956NM640 26020 GON4101170 26021 215728OPT640 26025 410543NUC640 26026 GON1425747 26028 715735OPT1 000000BRI00069 405456NM615 SAN00215 615893MMCT1 00000000107BH3 DZ1060NM01 89315HL6 GON4054688 21002 0910263235 21013 0910263223 21017 0910262297 21020 0910262304 21029 0910263228 21039 0910263231 21041 0910262310 21049 0910263243 21066 0910262319 21075 0910262322 21079 0910267022 21080 0910263239 21081 0910264141 21082 0910262325 21119 0910264135 21140 0910265075 21144 0910265074 21145 0910262344 21147 0910264147 21150 0910263250 26002 0910263256 26005 0910263253 00000000103BH2 0910263259 00000000124BH8 83092327843 00000000129BH7 83092719500 00000087514HL6 83092962829 00000333837HM3 83091096402 96BH8 0910265076 97761HL1 83095572382 21001 010120NU19 21008 110022NU05 21034 030133NU13 21050 210060NU02 21056 110017NU06 21104 030082NU13 21132 100032NU05 21162 190163NU04 21167 190163NU06 21178 080041NU04 21179 030360NU01 21214 030037NU08 21215 100039NU02 21229 210002NU11 22003 030359NU07 22020 030232NU15 22038 030029NU05 22080 GON4038416 24019 030151NU17 210088 190052NU09 000000BRI0099 030151NU15 22073 NM22073 22074 NM22074 22118 NM22118 22120 NM22120 22130 NM22130 24011 NM24011 24014 GON1423009 21164 BG4009NM01 21042 204726D670NM 21048 514848D670 21058 819563D670 21061 514281D670 21077 514842AD670 21085 905883D670 21094 519973D670 21115 613548D670 21122 418549D670A 21123 418549D670B 21135 905684D670A 21137 514338D670 21139 90

Risk classification

Class II

Area (FDA)

device

Country

United States