Events

Device Recall The MXR35 Xray Generator's. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fujifilm Medical System USA, 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
    67958
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1642-2014
  • 사례 시작날짜
    2012-06-29
  • 사례 출판 날짜
    2014-05-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126664
  • 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
    Full field digital,system,x-ray,mammographic - Product Code MUE
  • 원인
    The mxr-35 x-ray generator's labeling did not include the certification statement as required by 21 cfr part 10 10.2.
  • 조치
    Fujifilm will replace the violative labels with replacement labels provided by DRGEM, to bring the X-ray generator into compliance. You stated that you expect for all nine installed units to be corrected by the end of May 2014. The seven units in the Stamford, CT warehouse will be corrected when the generators are delivered to customer sites. Under 21 CFR 1003.31(c)(2), this exemption is granted subject to the following conditions: 1. You must correct the missing certification statement for all units shipped into the US within the timeline you specified, by the end of May 2014. 2. You must ensure that all future units that will be delivered and installed in the US will be in compliance with the labeling requirement, per 21 CFR 1010.2.

Device

Device Recall The MXR35 Xray Generator's.
  • 모델명 / 제조번호(시리얼번호)
    SN: MXA1170108, MXA1270262
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
  • 제품 설명
    MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. || x-ray generator
  • Manufacturer
    Fujifilm Medical System USA, Inc.

Manufacturer

Fujifilm Medical System USA, Inc.
  • 제조사 주소
    Fujifilm Medical System USA, Inc., 419 West Ave, Stamford CT 06902-6343
  • 제조사 모회사 (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA