Events

Device Recall Zippie TS wheelchair 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
    61082
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1103-2012
  • 사례 시작날짜
    2012-01-13
  • 사례 출판 날짜
    2012-02-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107257
  • 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
    One zippie ts wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use.
  • 조치
    Sunrise Medical contacted customer by telephone on January 17, 2012 to arrange for removal of transit brackets. The Sunrise Sales rep then visited the customers on January 18, 2012 and removed the bracket from the chair making it appropriate for intended use. If you need any additional information or have any questions, call 559-348-2572 or email: laurie.roberts@sunmed.com.

Device

Device Recall Zippie TS wheelchair
  • 모델명 / 제조번호(시리얼번호)
    Model number: E1Z1A; Serial number: Z1SE-006474.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: OK only.
  • 제품 설명
    Sunrise Medical Zippie TS wheelchair || To empower physically challenged person by providing a means or mobility.
  • 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