O-ARM 1000 Imaging System

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    SATP

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic O-arm 1000 Imaging Systems
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    O-Arm 1000 Imaging System, Medtronic Navigation Inc
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    9732719, 9733346, BI-700-00027-100, BI-700-00027-120, BI-700-00027-230
  • 제품 설명
    MD: Fluoroscopic x-ray system, general-purpose, portable, digital
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    BI-700-00027 and BI-700-00028 | All
  • 제품 설명
    MD: Portable general-purpose fluoroscopic x-ray system, digital; Radiographic/fluoroscopic unit, general-purpose
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
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