Device Recall Brilliance iCT CT XRay System

  • 모델명 / 제조번호(시리얼번호)
    Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of DC, IL, IN, OH, PA and VT and the countries of Belgium and Israel.
  • 제품 설명
    Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. || The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA