Events

Device Recall PROFlex Transporter, model 35P. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ferno-Washington 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
    34010
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0202-06
  • 사례 시작날짜
    2003-03-28
  • 사례 출판 날짜
    2005-11-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42908
  • 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
    Stretcher, Wheeled - Product Code FPO
  • 원인
    The firm received complaints of the stretchers folding. a fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher.
  • 조치
    The firm went out to customers who had complained of a 'fold' and installed the kit on the stretcher that had experienced the fold and on all other PROflexx stretchers owned by the customer. These customers had received a recall letter, dated March 28, 2003. For customers that had not complained of the stretchers 'folding', the firm sent a letter dated June 24, 2003, to all distributors requesting the distributor provide the firm with a list of customers that had received the PROflex stretchers. Once the firm had a list of all customers, they sent them a letter offering them the kit as an enhancement that they could purchase to help reduce the possibility of false locking.

Device

Device Recall PROFlex Transporter, model 35P.
  • 모델명 / 제조번호(시리얼번호)
    All stretchers containing a serial number beginning with the letter ''L'' and followed by a sequence of six numbers.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was distributed nationwide to 27 states: TN, MA, VT, IL, KY, NY, SC, WI, TX, MO, NH, CO, GA, NC, CA, VA, IA, PA, CT, OH, NJ, ID, WV, AL, AR, ME and IN.
  • 제품 설명
    PROFlex Transporter, Model number 35P. The catalog number for the model 35P is PT3550.
  • Manufacturer
    Ferno-Washington Inc

Manufacturer

Ferno-Washington Inc
  • 제조사 주소
    Ferno-Washington Inc, 70 Weil Way, Wilmington OH 45177-9371
  • 제조사 모회사 (2017)
    Ferno-Washington Inc.
  • Source
    USFDA