Device Recall Medline Excel Shuttle Wheelchair, 24" Wide 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medline Industries 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
    47781
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1770-2008
  • 사례 시작날짜
    2008-03-31
  • 사례 출판 날짜
    2008-08-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-05-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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 Wheelchair - Product Code IOR
  • 원인
    Fingers can get injured. there is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. injuries can be severe from fractures to severing.
  • 조치
    A Voluntary Field Correction letter dated 3/31/08 was issued to customers. The letter informed them of reports of users catching their fingers under the seat bars, which are identified on the chair with warning stickers. The customers were requested to change the backrest with the enclosed replacement upholstery kit, properly dispose of the old back rest, and place the enclosed cautionary tags on both sides of the chair seat. Instructions for installation of the upholstery and cautionary tags were included, as was a sheet entitled "How to Open a Wheelchair" which gives step by step instructions with illustrations for opening the wheelchair, as well as the warning "CAUTION KEEP YOUR FINGERS ON TOP OF THE UPHOLSTERY AT ALL TIMES. DO NOT PLACE YOUR FINGERS ON THE SIDES OR BOTTOM OF THE CHAIR SEAT." The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the serial numbers of chairs corrected. Any questions were directed to 800-633-5463, extension 5349, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    Item numbers MDS809600 and MDS809650; all wheelchairs purchased between 12/01/2005 and 08/31/2007
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Worldwide Distribution --- including USA and Canada.
  • 제품 설명
    Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; || Item #MDS809600 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Fixed Height. || item #MDS809650 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Fixed Height.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA