Device Recall Discovery NM/CT 670

  • 모델명 / 제조번호(시리얼번호)
    System ID: 0828260021, 0828260022, 0850260118, 0850260122, 0850260128, 0850260131, 0850260132, 0853260094, 0853260099, 0856260033, 0856260034, 0856260035, 0910262297, 0910262304, 0910262310, 0910262319, 0910262322, 0910262325, 0910262344, 0910263223, 0910263228, 0910263231, 0910263235, 0910263239, 0910263241, 0910263243, 0910263250, 0910264135, 0910264141, 0910264147, 0910265074, 0910265075, 0910265076, 0920269097, 082426040043, 082426040044, 082426060005, 082426070028, 082426070030, 082426080020, 082426090029, 082426090030, 082426130029, 082426130030, 082426150026, 082426160042, 082426210020, 082426230020, 083026009408410, 083026023683711, 083026201006810, 00001NUC12, 00028NUC01, 00042NUC02, 00046NUC06, 00065NUC08, 00123NUC01, 00149NUC01, 00149NUC03, 00197NUC14, 00199NUC13, 00200NUC07, 00200NUC08, 00234NUC09, 00361NUC08, 00432NUC02, 010120NU19, 030037NU08, 030082NU13, 030133NU13, 030360NU01, 05462NUC05, 06007NUC19, 080041NU04, 100032NU05, 10497NUC20, 110017NU06, 110022NU05, 11018NUC08, 190052NU09, 190163NU04, 190163NU06, 204726D670NM, 210060NU02, 212639NMD670, 250370D670, 260010NU06, 262574D670, 305674D670, 309671SPECT, 403343D670, 403943D670, 403943D670B, 404686NMCT, 410955D670, 410D6701, 415353D670, 416495D670, 418549D670A, 418549D670B, 423495D670, 514281D670, 514338D670, 514842AD670, 514848D670, 514876D670, 519973D670, 529150NU05, 540332D670, 600092NM11, 610402D670NM1, 613548D670, 614NCH670, 615322NM5, 615893MMCT1, 617638DSV670, 630432D670, 720848D670, 803751D670, 819563D670, 819563D670B, 856247D670, 856247NM, 900010NU09, 905472D670, 905684D670A, 905684D670B, 905883D670, 972747NM670, 972935D670, A4169312, A4194844, A51051127, A51142126, A5125139, A5129983, A5196344, B4182011, B5140618, BG4009NM01, D007NU12, DK1029NU14, DK1047NM01, EE1020NM03, FE416061, FI1052MN01, GP1000NM01, HOR0281, IL1020NM36, IL1041NM30, IL1062NM29, M001NU42, M2002713, M251400603, M4134637, M4143630, M4143993, M4144126, M4145158, M4194042, M4198090, M4210246, M4215577, M4476424, M4505290, M5172553, M5400562, M5480777, M9409545, M9886847, MEX68915, NO1018MN06, NO1087MN09, NO1088MN16, NT1001, NT1002, NT1003, NT1004, NT1005, NT1006, NT1007, NT1008, NT1009, NT1010, NT1011, NT1013, NT1015, NT1020, NT2001, NT2002, O005NU27, PC8262NU01, PITT670, RTD0737, RU1095NM03, RU1279NM02, RU1949NM01, RU3451NM01, RU3467NM01, RU3623NM01, RU3637PT01, RU3713NM01, RU3900NM01, RU6340NM01, RU7175NM01, RU7187NM01, RU7505NM01, UX2305NU01, V4144610, V4169306, X102874005, X4144501, XM203402.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
  • 제품 설명
    Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. || Product Usage: The GE Discovery NM/CT 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.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA