Events

Lumex 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Graham Field Atlanta 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
    37747
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0772-2007
  • 사례 시작날짜
    2007-04-02
  • 사례 출판 날짜
    2007-05-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-01-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51451
  • 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
    Rollator - Product Code ITJ
  • 원인
    The caster bolt stem/screw may loosen over time causing the wheel to come off.
  • 조치
    Graham-Field notified all of its Durable Medical Equipment (DME) dealers involved in the distribution of these products by certified US Mail on April 3, 2007. They were made aware of the need to adjust the product to lessen the risk of injury and were provided a re-work kit. The distribution of DME dealers includes the announcement of the field correction to the DME dealer, the letter to send to the end-users, rework supplies, rework instructions and proof of compliance cards. Graham-Field instructed the DME dealers to adjust any impacted products on site, as well as, any delivered by end-users, customers or other impacted third parties to the DME dealer for correction. DME dealers will be compensated for performing the corrective action. The installation of the rework kit involves the installation of lock washers and Locitite and is described in more detail in the attached rework instructions. Graham-Field does not have direct access to end user names, however it plans to reach end-users by financially supporting a certified mailing from DME dealers to their individual customers notifying them of this field correction. A follow-up 60 day certified mailing will be performed for non-responders.

Device

Lumex
  • 모델명 / 제조번호(시리얼번호)
    Model numbers: RJ4300B, RJ4300D, RF4300G, RJ4300K, RJ4300R, and Imperial Model RF4400K. (Note: Models distributed after January 2007, serial numbers 120791 through 145254, are not subject to this correction)
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    U.S. Nationwide, Costa Rica, Ecuador, El Salvador, Guatemala, and Santo Domingo
  • 제품 설명
    Lumex¿ Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.
  • Manufacturer
    Graham Field Atlanta

Manufacturer

Graham Field Atlanta
  • 제조사 주소
    Graham Field Atlanta, 2935 Northeast Pkwy, Atlanta GA 30360-2808
  • Source
    USFDA