Events

Device Recall Manual Wheelchairs with Transit System Option 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sunrise Medical 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
    51260
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0831-2011
  • 사례 시작날짜
    2009-02-02
  • 사례 출판 날짜
    2010-12-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-01-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79491
  • 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
    The stabilizer bar was inadvertently omitted during the manufacturing process.
  • 조치
    An Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168.

Device

Device Recall Manual Wheelchairs with Transit System Option
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers:  LXI-034554, LXI-034697, LXI-034694, LXI-034500, LXI-034609, LXI-034740, and  LXI-034741.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States and Canada.
  • 제품 설명
    Manual Wheelchairs with Transit System Option, || Model: Quickie LXI (EILXI), || Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA || Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
  • Manufacturer
    Sunrise Medical Inc

Manufacturer

Sunrise Medical Inc
  • 제조사 주소
    Sunrise Medical Inc, 2842 N Business Park Ave, Fresno CA 93727-1328
  • Source
    USFDA