Device Recall Biograph mCT X4R

  • Modelo / Serial
    Serial Numbers: 1008, 11016, 11017, 11022, 11029, 11036, 11054, 11066, 1010, 1004, 11063, 11027, 11055, 11056, 11058, 11057, 11060, 11064, 11070, 21074, 1003, 1005, 1009, 11015, 11023, 11037, 11042, 11045, 11047, 11052, 11059, 11065, 11031, 1002, 11061, 11068, 1006, 11019, 11041, 11048, 11038, 11039, 11014, 11021, 11028, 11030, 11034, 11069, 21071, 11018, 11013, 11040, 11067, 11025, 11049, 11051, 11050, 11046, 11062, 1007, 1011, 11012, 11020, 11024, 11026, 11035, 11043, 11044, 21072, 21073, 1001
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.
  • Descripción del producto
    Biograph mCT X-4R, Material Number 10248670 || The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Siemens Medical Solutions USA Inc., 810 Innovation Dr, Knoxville TN 37932-2562
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

2 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Serial Number: 1003
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
  • Descripción del producto
    Biograph mCT X-4R, System Material Number 10248670. || The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
  • Manufacturer
  • Modelo / Serial
    SERIAL NUMBERS: 1009, 11061
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.
  • Descripción del producto
    Biograph mCT X-4R, Model Number 10248670
  • Manufacturer