Events

Device Recall Mechanical Walker/Rollator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Essential Medical Supply, 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
    52129
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1674-2009
  • 사례 시작날짜
    2009-05-08
  • 사례 출판 날짜
    2009-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82166
  • 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
    Mechanical Walker - Product Code ITJ
  • 원인
    The caster may separate from the frame completely causing injury to the user.
  • 조치
    Essential Medical Supply Inc issued a Notice of Quarantine Letter to all customers on 04/30/09, identifying affected products as W1700B & W1700R Essential Rollators, Serial #'s KLD-E07090001 through KLD-E08020570, received after 11/05/2007. Firm issued a Device Recall Letter to all direct customers on 05/08/09 instructing them to do the following: (1) segregate and quarantine any affected product; (2) identify and notify any customers that may received the affected products, instructing them to return the product to their dealer; and (3) either return the affected products to Essential Medical Supply or destroy the products and send proof of destruction.

Device

Device Recall Mechanical Walker/Rollator
  • 모델명 / 제조번호(시리얼번호)
    W1700 (R and B); Lot / Serial Nos.: KLD-E07090001 through KLD-E08020570
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator
  • Manufacturer
    Essential Medical Supply, Inc.

Manufacturer

Essential Medical Supply, Inc.
  • 제조사 주소
    Essential Medical Supply, Inc., 6420 Hazeltine National Dr, Orlando FL 32822-5121
  • 제조사 모회사 (2017)
    Essential Medical Supply Inc
  • Source
    USFDA