Events

Device Recall Liko AB Uno Lifts 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Liko North America Inc 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
    50155
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0605-2009
  • 사례 시작날짜
    2008-11-11
  • 사례 출판 날짜
    2009-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74870
  • 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
    Actuator of the lift has the potential to separate when the upper arm is fully extended.
  • 조치
    Hill Rom notified customers with a Field Safety Notice, dated December 5, 2008 to notify customers of the issue, potential risks, and to inspect units per their instructions and remove units from service if the unit fails inspection. Hill-Rom will provide a permanent fix, using an "OuterTube" to be placed on all units.

Device

Device Recall Liko AB Uno Lifts
  • 모델명 / 제조번호(시리얼번호)
    Uno 100: S/N 7090001 through 7096200 Uno 101: S/N 10001 through 1000 Production Dates: Manufactured prior to June 26, 2008
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and country of Canada.
  • 제품 설명
    Liko AB Uno Lifts, Powered (non-AC) Patient Lift: || Uno 100 EM/EE: S/N 7090001 through 7096200 || Uno 101: S/N 10001 through 11000 || Production Dates: Manufactured prior to June 26, 2008 || Uno 100 and 102 are battery powered mobile lifts, designed to be used in most of the common lifting situations, for example transfers between bed and wheelchair, to and from the toilet and bathtub or for lifting to and from the floor.
  • Manufacturer
    Liko North America Inc

Manufacturer

Liko North America Inc
  • 제조사 주소
    Liko North America Inc, 122 Grove St, Franklin MA 02038-3159
  • Source
    USFDA