Events

Device Recall Brilliance Big Bore Oncology CT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) 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
    79134
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0840-2018
  • 사례 시작날짜
    2018-01-03
  • 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=161425
  • 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, tomography, computed - Product Code JAK
  • 원인
    Software issues including: software errors that may result in extended field of view check message not displayed when field of view is set >600 mm for a paused scan; request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the ct simulation exam card; software errors that may result in tumor loc allowing poi (point of interest) locking when a non-isocenter slice is displayed; software errors that may result in partial set of images or inability to generate ct images.
  • 조치
    Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated January 2, 2018 to their customers. The letter identified the affected product problem and actions to be taken. For questions contact your local Philips representative or local Philips Healthcare office.

Device

Device Recall Brilliance Big Bore Oncology CT
  • 모델명 / 제조번호(시리얼번호)
    Brilliance Big Bore Oncology CT, Model # 728243 Serial #s: 76025 76022 76024 76023 76016 76021 76008 76010 76002 76020 76011
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide
  • 제품 설명
    Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 || Product Usage: || Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA