Device Recall Siemens mMLC (ModuLeaf)

  • 모델명 / 제조번호(시리얼번호)
    ModuLeaf, 110V/60Hz, part number 7334043; ModuLeaf, 220V/60Hz, part number 7334050.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: CO, IA, KY, NJ, OH and TX; and countries of: Algeria, Austria, Belgium, Brazil, China, Egypt, France, Germany, Hungary, India, Italy, Japan, Kuwait, Malaysia, Mexico, P.R., Russian Fed., Saudi Arabia, South Africa, Spain, Turkey, and United Kingdom.
  • 제품 설명
    Siemens mMLC (ModuLeaf) safety bar and trolley label. || Siemens Medical Solutions USA, Inc. || Concord, CA. || The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer. This accessory shapes the radiation beam, per the leaf parameters, to minimize the amount of dose to outlying tissue.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA