Device Recall Minstrel Patient Lift 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arjo, 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
    36187
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0478-2007
  • 사례 시작날짜
    2006-08-31
  • 사례 출판 날짜
    2007-01-11
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-10-16
  • 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
    patient lift - Product Code FNG
  • 원인
    The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.
  • 조치
    Arjo sent an Urgent Device Field Correction Recall letter dated 8/31/06 to all affected end users to the attention of the Administrator/Risk Manager via FedEx on the same date. The letters informed the accounts of the potential for the hanger bar to detach from the scale due to fatigue failure of the pivot bolt. The accounts were advised that an Arjo Field Service Technician would contact them within five business days to schedule a visit to the account to perform an upgrade of their Minstrel lifts. Any questions were directed to Arjo Quality Department at 800-323-1245, ext. 6140.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model number HMB002-US, all serial numbers manufactured prior to June 2004. The production date can be determined by the serial number on the mast of the lift. Serial numbers start with MPLA or MPLAT, followed by the last two digits of the year and two digits for the month of production, i.e. MPLA0103 = March 2001.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model number HMB002-US
  • Manufacturer

Manufacturer

  • 제조사 주소
    Arjo, Inc., 50 Gary Ave, Roselle IL 60172-1605
  • Source
    USFDA