Events

OR Table, Top 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Trumpf Medical 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
    75412
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0391-2017
  • 사례 시작날짜
    2016-10-25
  • 사례 출판 날짜
    2016-11-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150224
  • 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
    Trumpf has identified six incidents of pinched cables.
  • 조치
    Trumpf Medical sent an Urgent Medical Device Correction letter dated October 7, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken The letter indicated that a authorized service provider will inspect the table tops and make necessary corrections. A confirmation notice was included with the letter which is to be returned. For contact Trupmpf Medical Systems, Inc. at 888-¿474-¿9359.

Device

OR Table, Top
  • 모델명 / 제조번호(시리얼번호)
    Model # 190973 - Serial Number Range 102394262 - 102974610; Model # 1909794 - 102884276; Model # 1909796 - 102440024 - 102981676; Model # 1909797 - 102757564 - 102958935; Model # 1909798 - 102831498 - 102831519; Model # 1909799 - 102393683 - 102969656
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of AZ and SC and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, Italy, Norway, Qatar, Slovenia, Spain, Sweden, Switzerland
  • 제품 설명
    OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 || Product Usage: || Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • 제조사 주소
    Trumpf Medical Systems, Inc., 1046 Legrand Blvd, Charleston SC 29492-7672
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA