Events

Device Recall ProFx 6850 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mizuho Orthopedic Systems Inc 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
    56859
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0924-2011
  • 사례 시작날짜
    2010-03-30
  • 사례 출판 날짜
    2011-01-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94677
  • 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
    Ac-Powered Surgical Table with Orthopedic Accessories - Product Code JEA
  • 원인
    Device component spar gear box locks up and may result in failure of push pull tube, which may result in release of breaking and impact.
  • 조치
    All customers will be contacted to arrange for removal and shipping arrangements. Verification will be done by the Repair and Verification instructions for the leg spars, via registered letters. *******UPDATED INFO---The firm sent another notification letter---dated 12/22/10---which states in part: "****The upgrade involves the correction of your 6850 PROfx¿ spars (6850-2100) at your facility by a Qualified Technician. The spars shall be upgraded to remove the 6850-2123, Drive Bracket, Spar Push Rod and replace it with the 6850-2170, Drive Bracket, Spar Push Rod. Upon completion of the upgrade, the 6850-2123, Drive Bracket, Spar Push rod shall be returned to Mizuho OSI for processing.*******

Device

Device Recall ProFx 6850
  • 모델명 / 제조번호(시리얼번호)
    all units.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA & Germany.
  • 제품 설명
    Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA.
  • Manufacturer
    Mizuho Orthopedic Systems Inc

Manufacturer

Mizuho Orthopedic Systems Inc
  • 제조사 주소
    Mizuho Orthopedic Systems Inc, 30031 Ahern Ave, Union City CA 94587
  • 제조사 모회사 (2017)
    Mizuho Co. Ltd.
  • Source
    USFDA