Events

TruSystem 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
    66688
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0342-2014
  • 사례 시작날짜
    2013-10-28
  • 사례 출판 날짜
    2013-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122967
  • 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, manual - Product Code JEB
  • 원인
    The coupler point (hood) of the leg section one part light may become detached from the leg section frame.
  • 조치
    TRUMPF sent an Urgent Safety Information letter dated October 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to inspect Leg Section One Part Light for damage to the coupler point (hook) between each case. If any damage is noticed to the coupler, they were instructed to stop use immediately and contact TRUMPF Technical Service. If they drop or collide the Leg Section One Part Light into anything then stop use immediately and contact TRUMPF Technical Service. Review the User Instruction for proper use and care of the device. The leg section should be used only as intended as part of the TRUMPF TS7000 surgical table. The intended use is to support and position the patients legs during the pre-operative and post-operative stages of surgery. The leg section should be removed during surgery. TRUMPF will be exchanging the hooks, counter plates and screws of the coupler point to increase the area that the load is distributed over. This will allow the screws securing the hood to the leg frame to withstand external forces. TRUMPF anticipates parts to be available the first week of November. TRUMPF trained technicians will complete the TRUMPF Medical Systems, Inc. for the part exchange. Completion is anticipated by November 11, 2013. Further questions please call (843) 534-0606

Device

TruSystem
  • 모델명 / 제조번호(시리얼번호)
    Item no. 1739993, All serial numbers.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
  • 제품 설명
    TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU || Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • 제조사 주소
    Trumpf Medical Systems, Inc., 415 Jessen Ln, Charleston SC 29492-7906
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA