Device Recall OPTICAL BIOMETER

  • 모델명 / 제조번호(시리얼번호)
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Serial numbers: 220005, 220006, 220008, 220009, 220013, 220017, 220018, 220019, 220020, 220021, 220023, 220025, 220026, 220031, 220032, 220033, 220036.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.
  • 제품 설명
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. || Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • 제조사 모회사 (2017)
  • Source
    USFDA