Device Recall Cmax 110v Surgical Table Hand Control 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Steris Corp 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
    52172
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1599-2009
  • 사례 시작날짜
    2009-05-12
  • 사례 출판 날짜
    2009-07-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-02-26
  • 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, operating-room, ac-powered - Product Code FQO
  • 원인
    A limited quantity of the cmax hand controls, p150832-500, were manufactured without loctite thread locker on the screws that attach the mounting clip to the hand control case. this clip provides a means of storing the hand control on the table side rails. it is possible that screws without loctite can work loose and the clip can become separated from the hand control. if both screws back out c.
  • 조치
    Steris Corp. issued an "Urgent Product Correction" notice dated May 12, 2009 informing consignees of the affected device and that a Steris Service Representative with be in contact to make the necessary inspection and repairs to the device. Steris Field Service Dispatch can be reached at 1-800-288-2805. For further questions, contact Steris at 1-800-548-4873 extension 27318.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Number(s): 2182625; Serial Numbers: AC0001 to AC0221.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- U.S. states of AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI and WV and countries of Canada and Taiwan.
  • 제품 설명
    Cmax 110v Surgical Table Hand Control. || The Cmax Surgical Table is a mobile, electro-hydraulically operated || surgical table designed to support all general surgical procedures, with the || addition of STERIS table accessories. Tabletop positioning and || articulations are controlled via the hand control.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Steris Corp, 5960 Heisley Rd, Mentor OH 44060
  • Source
    USFDA