Devices

Device Recall Olympus ImageManager

  • 모델명 / 제조번호(시리얼번호)
    Versions 6.0 through 6.4
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico.
  • 제품 설명
    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.
  • Manufacturer
    Olympus America Inc.
  • 1 Event

제조사

Olympus America Inc.
  • 제조사 주소
    Olympus America Inc., Two Corporate Center Drive, Melville NY 11747
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

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Device Recall Olympus ImageManager Software
  • 모델명 / 제조번호(시리얼번호)
    Versions 6.0 through 6.4.1 (excluding version 6.3.8)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.
  • 제품 설명
    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) || Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking. It is a condition of the software malfunction that the observed image crosslink results from the collision of data files from two separate ImageManager computers.)
  • Manufacturer
    Olympus America Inc.