Devices

Device Recall Radionuclide Radiation Therapy System

  • Model / Serial
    Serial Numbers: 6004-6006, 6009-6012, 6014-6018, 6020-6023, 6025, 6027 and 6029-6032.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.
  • Product Description
    Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. || Indicated for use in the stereotactic irradiation of intracranial structures.
  • Manufacturer
    Elekta, Inc.
  • 1 Event

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA

One device with a similar name

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Device Recall Radionuclide radiation therapy system
  • Model / Serial
    Serial Numbers: 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6045, 6047, 6048, 6049, 6053, 6054, 6056, 6057, 6059 and 6061.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AZ, CA, FL, IL, KY, MI, MN, MS, MO, NY, NC, OH, OR, PA, SC, TX, UT and VA.
  • Product Description
    Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. || Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
  • Manufacturer
    Elekta, Inc.