Events

Device Recall Padded, swingaway armrests on Quickie Q7, GT, GTi and Zippie Zone wheelchairs 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
    62493
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2113-2012
  • 사례 시작날짜
    2012-06-26
  • 사례 출판 날짜
    2012-07-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110756
  • 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
    Reports of injury when the padded swing away armrest is used for full body weight. owner's manual states that armrest is only designed for resting of forearm.
  • 조치
    Sunrise Medical sent a Safety Notice letter dated June 25, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter request that clinicians/suppliers post this safety notice in a conspicuous location, making customers and therapists aware of the issue. The letter also encourage end users to read the owner's manual and follow the recommenations for proper usage of the recalled product. Customers are instructed to complete and return the Supplier Notification and Response Form. For questions contact Sunrise Medical Regulatory Affairs at 888-208-4901.

Device

Device Recall Padded, swingaway armrests on Quickie Q7, GT, GTi and Zippie Zone wheelchairs
  • 모델명 / 제조번호(시리얼번호)
    Receiver Product number 109207.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
  • 제품 설명
    Padded Swing Away Arm Rest with Receiver; || Uses on wheelchair models: || Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). || Product Usage: || To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
  • 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