Events

IFit" Shower Chair 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Invacare Corporation 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
    62965
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2461-2012
  • 사례 시작날짜
    2012-08-06
  • 사례 출판 날짜
    2012-09-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-02-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112225
  • 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
    Chair and table, medical - Product Code KMN
  • 원인
    On august 6, 2012, invacare voluntarily recalled the invacare¿ i-fit" shower chair (models 9780, 9781, 9781-1) based on the return, quality and adverse event data received.
  • 조치
    Invacare sent an "URGENT: RECALL INFORMATION" letter dated August 31, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of any affected product and to call the Recall Support Line at 877-496-5041 for assistance.

Device

IFit" Shower Chair
  • 모델명 / 제조번호(시리얼번호)
    9780, 9781, 9781-1
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of AUSTRALIA, CANADA, GUAM, ISRAEL, NEW ZEALAND, THAILAND, TRINIDAD AND TOBAGO.
  • 제품 설명
    Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. || These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • 제조사 주소
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • 제조사 모회사 (2017)
    Invacare Corporation
  • Source
    USFDA