Events

CombiDiagnost R90 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Electronics North America Corporation 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
    78880
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0330-2018
  • 사례 시작날짜
    2017-10-19
  • 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=160799
  • 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
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    The tube adapter-plate green/yellow protective earthing (pe) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance.
  • 조치
    Philips Medical System sent an Customer Notification letter dated October 19, 2017, and plans to have a Philips Field Service Engineer go to site to perform the field change order (FCO70900041) including: 1. Check for the presence of the PE cable and, if missing, install it. 2 .Perform a modified screw fixation. They expect to complete action by May 2018. For further questions, please call (978) 659-3000.

Device

CombiDiagnost R90
  • 모델명 / 제조번호(시리얼번호)
    All CombiDiagnost R90 UDI 709030
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.
  • 제품 설명
    CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system || CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • 제조사 주소
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA