Device Recall Microstream FILTERLINE SET ADU/PED

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
  • 제품 설명
    Microstream FILTERLINE SET ADU/PED 25UN || Part Number: XS04620-01 Oridion || XS04661 Physio Control
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • 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