Events

Device Recall Trumpf Medical 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
    72542
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0563-2016
  • 사례 시작날짜
    2015-11-02
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141498
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • 원인
    The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
  • 조치
    TRUMPF sent an " Urgent Field Safety Information" letter dated December 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the customer: 1. Perform an inspection of the lighting systems (see Appendix 1 for instructions). If any of the symptoms listed below are observed, immediately remove the light from operation and contact your Trumpf Medical Service Representative or designee. Signs that indicate a possible fall of the spring arm: The movement of the light and spring arm is difficult for the user, The lights have stopped being operational, and/or A gap is noticed between the spring arm and the central axis (see the attached Appendix 1 for an example). 2. Follow the User Manual: No unauthorized servicing of the spring arm is permitted. Snap rings are one use only and replacements must be purchased from your authorized Trumpf Medical partner. If you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359

Device

Device Recall Trumpf Medical
  • 모델명 / 제조번호(시리얼번호)
    4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.
  • 제품 설명
    Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
  • 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