Maxi Move Scoop Stretcher 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ArjoHuntleigh 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    52824
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2230-2009
  • 사례 시작날짜
    2009-08-18
  • 사례 출판 날짜
    2009-09-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-01-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Non-AC-powered Patient Lift - Product Code FSA
  • 원인
    A scoop stretcher is made up of two frames that are held together with two locking devices, one on each end. each locking device contains a safety latch. the safety latch could unintentionally release when the side frames are pulled for positioning.
  • 조치
    ArjoHuntleigh sent their customers a cover letter and the Field Safety Notification, informing them of the potential problem with the safety latches on the stretcher and a pending visit from an ArjoHuntleigh Service Technician to correct the problem. These letters were sent via UPS 2nd day delivery on 8/18/09. The customers were requested to test their stretchers upon receipt of the letter following the instructions for checking the safety latches on the stretcher: * Place the stretcher on its side on a non-scratch surface. * Try to pull the two sides apart with the safety latch engaged. * Test both the head and foot ends of the stretcher. * If the stretcher pulls apart, remove it from use immediately. It is important to note that all affected stretchers will be upgraded, whether they fail the test or not.

Device

  • 모델명 / 제조번호(시리얼번호)
    all six digit serial numbers beginning with 6xxxxx and all serial numbers 08xxxxxxxx up to 0812001186.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Maxi Move Scoop Stretcher; Note: The stretcher is an accessory to the Maxi Move Patient Lift; Made by Arjo Hospital Equipment AB, Eslov, Sweden; product number KRA2210-20.
  • Manufacturer

Manufacturer

  • 제조사 주소
    ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • 제조사 모회사 (2017)
  • Source
    USFDA