Device Recall ICON

  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    Blackstone Medical: || ICON Modular Pedicle Screw System; || P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Blackstone Medical, Inc., 1211 Hamburg Tpke, Suite 300, Wayne NJ 07470
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 7 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    iConnect Access V4.0 or earlier with any version of Merge PACS and iConnect Access V4.1 with Merge PACS V6.5.4 or earlier
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
  • 제품 설명
    iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    iConnect Access V4.0 or earlier with any version of Ortho PACS and iConnect Access V4.1 with Ortho PACS V5.1.2 and earlier.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
  • 제품 설명
    iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Version: 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, and 8.80.2.1
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to: CO and OK.
  • 제품 설명
    iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. || iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Versions 3.0.1, 3.1, and 3.2
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made to medical facilities nationwide. Foreign distribution was also made.
  • 제품 설명
    iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Diacam, Multispect 2, Multispect 3 and e.cam camera systems with ICON workstations with ICON software version 9.5 and the optional Whole Body SPECT software.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Equador, Egypt, France, Germany, Great Britain, Georgia, Greece, Hong Kong, Israel, India, Italy, Jordan, Japan, Korea, Latvia, Mexico, Niger, Norway, New Zealand, Philippines, Pakistan, Poland, Russia, Saudi Arabia, SIngapore, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine and the Netherlands.
  • 제품 설명
    ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
  • Manufacturer
하나 더 2 건 더