Events

Device Recall Linet 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Linet Americas 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
    60857
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0738-2012
  • 사례 시작날짜
    2011-12-08
  • 사례 출판 날짜
    2012-01-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106652
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • 원인
    The premature failure of the remote handset buttons may result in unintended movement of the bed.
  • 조치
    Linet sent a notification letter dated December 9, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken. The letter states that firm Linet has decided to do a voluntary field correction to replace the recalled product. The replacement will be completed by the territory Representative (Linet Employee) who will replace the affected product for each customer personally. The replacement takes approximately 30 seconds and does not require the patient to be moved. For questions or concerns call 704-248-5650.

Device

Device Recall Linet
  • 모델명 / 제조번호(시리얼번호)
    Model numbers: 1GZ, 1GV, IS, 1GM, 1AG, 1MC and 1L.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of: AL, FL, KY, LA, MA, NC, NY, OH and the country of: Canada
  • 제품 설명
    Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. || Product Usage: || Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care.
  • Manufacturer
    Linet Americas Inc

Manufacturer

Linet Americas Inc
  • 제조사 주소
    Linet Americas Inc, 10430 Harris Oak Blvd, Ste A, Charlotte NC 28269-7511
  • 제조사 모회사 (2017)
    Linet Americas Inc.
  • Source
    USFDA