Device Recall Mizuho Orthopedic Systems, Inc. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mizuho OSI 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
    63991
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0810-2013
  • 사례 시작날짜
    2012-12-17
  • 사례 출판 날짜
    2013-02-13
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-04-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
  • 원인
    Possible instability of orthopedic table top. if the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. if this occurs, the orthopedic table spar may need to be replaced to ensure stability of the orthopedic table top.
  • 조치
    Mizuho sent a Recall Notification letter dated December 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Orthopedic Table Spar will be replaced at no cost by Mizuho technicians. Customers were informed the potential failure and were advised inspection of tables prior to use. If tables are experiencing the described failure, contact Mizuho Resource Group at 1-800-777-4674, option 2. .

Device

  • 모델명 / 제조번호(시리얼번호)
    Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA Distribution -- Worldwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, 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, SC, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Canada, Egypt, Finland, France, Germany, China, Israel, Italy, Japan, Netherlands, New Zealand, P.R. China, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Taiwan R.O.C., UAE and UK.
  • 제품 설명
    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Mizuho OSI, 30031 Ahern Ave, Union City CA 94587-1234
  • Source
    USFDA