Events

Device Recall Quickie Q7 wheelchair. Model EIR4 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sunrise Medical (US) LLC 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
    74596
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2290-2016
  • 사례 시작날짜
    2016-07-01
  • 사례 출판 날짜
    2016-07-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148019
  • 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
    Wheelchair, mechanical - Product Code IOR
  • 원인
    There is an observed failure of the backrest bracket which can fatigue over the life time of the product. when this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame.
  • 조치
    The firm began calling dealers to alert them to the recall and obtain primary contacts information. Dealers were then sent their list of Quickie Q7 wheelchairs that records show being sold by them and dealers are asked to return a list of chairs they are able to locate for correction. The first dealer letter was sent via e-mail on July 7, 2016.

Device

Device Recall Quickie Q7 wheelchair. Model EIR4
  • 모델명 / 제조번호(시리얼번호)
    Model EIR 4 13,000 + serial numbers. RES would not accept this number. Please see spreadsheet provided in documents.R4-007239 to R4-022394. Serial number range:
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US and Mexico, Japan, Chile, Kuwait, Columbia, Hong Kong, China, Uruguay, South Africa, Costa Rica, South Korea, Singapore, New Zealand, El Salvador, Bahrain, Uruguay, Lebanon, United Arab Emirates, Brazil, Argentina, Netherlands Antilles, British Virgin Islands,
  • 제품 설명
    Quickie Q7 wheelchair. Model EIR4 || Physical Medicine. || The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
  • Manufacturer
    Sunrise Medical (US) LLC

Manufacturer

Sunrise Medical (US) LLC
  • 제조사 주소
    Sunrise Medical (US) LLC, 2842 N Business Park Ave, Fresno CA 93727-1328
  • 제조사 모회사 (2017)
    Sunrise Medical (Us) Llc
  • Source
    USFDA