Device Recall Flexicair II

  • 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¿ II (Model number 13000) 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
  • 1 Event

제조사

  • 제조사 주소
    Hill-Rom Manufacturing, Inc., 4349 Corporate Rd, Charleston SC 29405-7445
  • Source
    USFDA

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

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model #13000, IBxxxxxx (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¿ II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.
  • 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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Canada
  • 제품 설명
    Flexicair¿ II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.
  • Manufacturer