Devices

Gemini GXL PET/CT scanner

  • Model / Serial
    serial numbers 4001-4019.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to customers within the US and to foreign customers located in Canada, France, Thailand, South Africa, and Italy.
  • Product Description
    Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.)
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
  • 1 Event

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 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

Device Recall GEMINI GXL PET/CT Scanners
  • Model / Serial
    The affected Serial Numbers are:  4004, 4039, 4045, 4068, 4080, 4104, 4112, 4115, 4117, 4118, 4121, 4127, 4132, 4139, 4146, 4152, 4156, 4158, and 4175.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Puerto Rico, Canada, Belgium, China, Denmark, Egypt, France, Germany, Hong Kong, India, Japan, Netherlands, Pakistan, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, and Sweden.
  • Product Description
    Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc