Device Recall FLEXICAIR MC3

  • 모델명 / 제조번호(시리얼번호)
    MC3, Serial numbers: IC xxxxxx (where xxxxxxx is a 6-digit number sequence).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.
  • 제품 설명
    FLEXICAIR MC3¿ Low Airloss Therapy unit
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Hill-Rom Manufacturing, Inc., 4349 Corporate Road, Charleston SC 29405
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    All serial numbers. The prefix "IC" is representative of a Flexicair¿ MC3 and a six digit number without a prefix is representative of a refurbished Flexicair¿ MC3.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Canada
  • 제품 설명
    Flexicair¿ MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA
  • 제품 설명
    Flexicair¿ MC3 (Model number: M4000) Low Airloss Therapy Units || For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.
  • Manufacturer