Events

Device Recall Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips 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
    68228
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0135-2016
  • 사례 시작날짜
    2014-05-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-06-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129602
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    In spine clinical workflows, cross reference lines may be used to determine the position of slices. in cases, where mobiview fused images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.
  • 조치
    Consignees were notified of the recall by letter sent May 2014. They were instructed to do the following: Do not perform planning or review planning of transversal images on fused sagittal images which were generated through Mobi View postprocessing Instead, review the planning of transversal scans only on the unfused stations. A Field Change Order with reference FC0781 00431 is being released that PHILIPS requires Philips field service engineers to disable the MobiView post processing software. When possible this will be done remotely. Once it becomes available, a software update will be installed which will address the reference line positioning issue with MobiView Should you need to communicate with Philips with regard to this program, please reference FC0781 00431. If you need any further information or support concerning this issue, please contact your local Philips representative or the Technical Support Line: 1-800-722-9377.

Device

Device Recall Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 ve...
  • 모델명 / 제조번호(시리얼번호)
    All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US: AL AR AZ CA CO FL GA IL IN KS KY MA MI NY OH OR PA SC TX VA VT WA OUS: Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Colombia Denmark Ecuador Estonia Ethiopia France Germany India Indonesia Iraq Ireland Italy Japan Jordan Korea, South Malaysia Mexico Netherlands New Zealand Norway Oman Palestine Poland Russian Federation South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom.
  • 제품 설명
    All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • 제조사 주소
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA