Devices

Device Recall Leksell Gamma Knife Perfexion

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032 and 6036.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- AR, AZ, CA, FL, IL, MI, MN, MS, MO, NJ, OH, OR, PA, UT and VA.
  • 제품 설명
    Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. || Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.
  • Manufacturer
    Elekta, Inc.
  • 1 Event

제조사

Elekta, Inc.
  • 제조사 주소
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

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Device Recall Leksell Gamma Knife Perfexion
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 6002, 6003, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, and 6030.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom.
  • 제품 설명
    Leksell Gamma Knife Perfexion, Article #715000. || Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
  • Manufacturer
    Elekta, Inc.