Devices

Device Recall Radionuclie radiation therapy system

  • Model / Serial
    4339, 4349, 5026, 4326, 5034, 4346, 4158, 4307, 4337, 4327, 4340, 5023, 5035, 5036, 4329, 4306, 4365, 4357, 5022, 4363, 4354, 4302, 4333, 4309, 4366, 4351, 4342, 4315, 4352, 4353, 4328, 5000, 4314, 4338, 4303, 4207, 4332, 4322, 4343, 4321, 4334, 4358
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) - including the states of: CA, CO, DAL, FL, GA, IL, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA, WI and Puerto Rico
  • Product Description
    Elekta Leksell Gamma Knife C 1.2, 4 and 4C || Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head 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