Events

iNX Wheeled Stretcher 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
    71983
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2826-2015
  • 사례 시작날짜
    2015-08-03
  • 사례 출판 날짜
    2015-10-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139518
  • 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
    Hole elongation in the telescoping load frame channel. a hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame.
  • 조치
    Ferno began calling their customers on 8/3/2015. The firm informed their customers of the following: To provide optimal Customer Experience and minimal disruption to your service, the iNX field action involves the following steps: " Exchange of your current iNX with a new iNX; " Participation in a brief training session; and " Inspection of your Ferno Model 175 antler and rail fastening system as requested by the Dept. of Transportation. As you await delivery of your new iNX, it is important you ensure proper function of the fastening system and iNX telescoping load frame.

Device

iNX Wheeled Stretcher
  • 모델명 / 제조번호(시리얼번호)
    Serial #s: 15F001703, 15F001704, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001715, 15F001717, 15F001719, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001728, 15F001729, 15F001730, 15F001731, 15F001732, 15F001733, 15F001734, 15F001735, 15F001736, 15F001737, 15F001738, 15F001739, 15F001740, 15F001741, 15F001742, 15F001744, 15F001745, 15F001746, 15F001747, 15F001748, 15F001749, 15F001750, 15F001751, 15F001752, 15F001753, 15F001754, 15F001755, 15F001756, 15F001757, 15F001758, 15F001759, 15F001760, 15F001761, 15F001762, 15F001763, 15F001764, 15F001765, 15F001766, 15F001767, 15F001768, 15F001769 5F001770, 15F001771, 15F001772, 15F001773, 15F001774, 15F001775, 15F001776, 15F001777, 15F001778, 15F001779, 15F001780, 15F001781, 15F001782, 15F001783, 15F001784, 15F001785, 15F001786, 15F001787, 15F001788, 15F001789, 15F001790, 15F001791, 15F001793, 15F001794, 15F001795, 15F001796, 15F001797, 15F001798, 15F001804, 15F001805, 15F001806, 15F001807, 15F001808, 15F001809, 15F001810, 15F001811, 15F001812, 15F001813, 15F001814, 15F001815, 15F001816 & 15F001850.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: CO, IA, IL, IN, KY, MD, MN, MO, NC, NJ, NY, OH, OK, OR, TX, VA, WA & WY and the countries of CANADA, AUSTRALIA, UNITED KINGDOM & NEW ZEALAND.
  • 제품 설명
    Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System || Product Usage: || Stretcher for pre-hospital patient transport.
  • 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