Device Recall Airo

  • 모델명 / 제조번호(시리얼번호)
    Serial #s: 2251 (#1)*, 2324 (#2), 2328(#3), 2344 (#4), 2346 (#5), AIRO-0106, AIRO-0107*, AIRO-0108, AIRO-0110, AIRO-0111, AIRO-0112, AIRO-0113, AIRO-0114, AIRO-0115, AIRO-0116, AIRO-0117, AIRO-0118, AIRO-0119, AIRO-0120, AIRO-0122, and AIRO-0123. *Demo system
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
  • 제품 설명
    Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Mobius Imaging, LLC, 323 W Main St, Ayer MA 01432-1239
  • 제조사 모회사 (2017)
  • Source
    USFDA