Device Recall STEALTHSTATION TREATMENT GUIDANCE PLATFORM

  • 모델명 / 제조번호(시리얼번호)
    Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    StealthStation S7 Framelink Software version 5.4. || Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • 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
    USFDA