Devices

Device Recall Hi Visionultrasound diagnostic scanners

  • 모델명 / 제조번호(시리얼번호)
    The following Serial Numbers of this device were subject to recall/software correction: 17084306, 17084308, 19921303, 17268307, 17268309, and 18190406.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX.
  • 제품 설명
    EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, || DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A.
  • Manufacturer
    Hitachi Medical Systems America Inc
  • 1 Event

제조사

Hitachi Medical Systems America Inc
  • 제조사 주소
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
  • 제조사 모회사 (2017)
    Hitachi Ltd
  • Source
    USFDA