Device Recall Philips 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
    72571
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0765-2016
  • 사례 시작날짜
    2015-11-03
  • 사례 출판 날짜
    2016-02-05
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-08-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • 원인
    Normally, movement of the c-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the c-arc. because of improper adjustment and tolerances, when the c-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued c-arc movement (c-arc is looking for balanced position).
  • 조치
    The letters for the customers in the United States were sent on 11/3/2015, via certified return receipt and were addressed to the Risk Manager. Philips will perform a test on the 15 affected Allura Xper R8.2 FD 20C systems to see if the motion controller amplifier of the brake motor works correctly. If the test will not pass, the motor will be replaced. The Recall Package is sent to all Key Markets worldwide. The Key Market of an affected country will contact the facility where these systems were installed.

Device

  • 모델명 / 제조번호(시리얼번호)
    Ceiling version only.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution. US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.
  • 제품 설명
    Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
  • Manufacturer

Manufacturer

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