Events

Device Recall Skytron Ergon 2 Skyboom 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Skytron, Div. The KMW Group, 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
    72897
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0655-2016
  • 사례 시작날짜
    2015-12-02
  • 사례 출판 날짜
    2016-01-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-07-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142447
  • 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
    The hardware that holds the vesa plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. over time and with use the threaded rod hardware material can weaken and detach from the bracket. a display interface falling from its mounting location may result in injury to the patient or provider.
  • 조치
    Skytron sent an Urgent Medical Device Recall letter dated December 02. 2015, to all affected customers via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions were instructed to contact at 616-656-2900 with any questions. For after-hours support, please call 1-800-SKYTRON.

Device

Device Recall Skytron Ergon 2 Skyboom
  • 모델명 / 제조번호(시리얼번호)
    Model Number(s): H8-010-50-FC2-LH and H8-010-50-FC2-RH. VESA plates distributed from 09/26/08 to 04/30/13.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including WI, TX, FL, NC, MD, OH, AZ, CA, UT, MT, OK, HI, CO, WY, MO, NJ, IL, NY, MA, IA, DE, PA, MI, IN, and WV and Internationally to Canada, and Japan.
  • 제품 설명
    Ergon 2 Articulating Equipment Boom Monitor Brackets || mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms
  • Manufacturer
    Skytron, Div. The KMW Group, Inc

Manufacturer

Skytron, Div. The KMW Group, Inc
  • 제조사 주소
    Skytron, Div. The KMW Group, Inc, 5085 Corporate Exchange Blvd Se, Grand Rapids MI 49512-5515
  • 제조사 모회사 (2017)
    The Kmw Group Inc
  • Source
    USFDA