Device Recall GEMINI TF64 Diagnostic Imaging System

  • Model / Serial
    The recalled system units are identified as follows: Model Number: 882476, and Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.
  • Product Description
    Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135, Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206. The recalled GEMINI TF Big Bore system units equipped with software version: 3.6.1 are subject to recall/software correction. || The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    The recalled system unit is identified as follows: Model Number: 882471 and Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.
  • Product Description
    Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164. The recalled GEMINI TF64 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. || The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
  • Manufacturer