Device Recall IQon Spectral CT with 4.7.2 software version. 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
    79148
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0841-2018
  • 사례 시작날짜
    2018-01-11
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • 원인
    23 software related issues for the iqon spectral ct with 4.7.2 software version. these issues include: " software errors that may result in ct spectral images misrepresentation or incorrect treatment; " software errors that may result in partial set of images or inability to generate ct images.
  • 조치
    Philips Healthcare is notifying the affected users of these issues via a Field Safety Notice and will be releasing a software fix via Field Change Order to correct these issues. They also provide the following instructions.: Issue 1, Uric acid application for gout provides inconsistent results - When reviewing images using the Uric Acid Spectral Result type inconsistent results were provided on gout studies. The tendons would occasionally be displayed as containing Uric Acid even with no or normal uric acid blood levels. Issue 2, Multi-phase Cardiac CTA Scans should include a planned conventional result for every planned spectral result - When planning a Cardiac multi-phase study, it is possible to create a phase that consists of only a Spectral Result. Issue 3, 0-MAR information is missing in DICOM when saving as original or Secondary Capture - When an SBl that was created with 0-MAR enabled is used to create and save any Spectral result: " DICOM information about 0-MAR is missing but the 0-MAR label appears on a result saved as Original " DICOM information and the 0-MAR label are both missing on a result saved as Secondary Capture Issue 4, Attenuation plot presents incorrect HU values for MonoE - When comparing HU values of an ROl to the values in the attenuation plot graph when using the Show spectral plots for this ROI option, there is a difference of 10-20 HU values between the ROI HU value and the value shown on the graph Issue 5, Windows Operating System Time Zone Updates - Microsoft Windows Daylight Savings Time Zone updates have not been applied since December 2014. This may cause the system time to be incorrect at the start and end of daylight savings time. Issue 6, Sending Calcium Score findings to report using Mass Score protocol provides confusing information - The Heartbeat CS (Calcium Scoring) option provides confusing information in the Impressions section of the Calcium Scoring report. The report provides m

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860025 860026 860027 860028 860029 860030 860031 860032 860033 860034 860035 860036 860037 860038 860039 860040 860041 860042 860043 860046 860048 860049 860050 860051 860052 860053 860054 860055 860056 860057 860058 860059 860060 860061 860062 860063 860064 860065 860066 860067 860068 860070 860071 860072 890002 860047
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Domestic and Foreign
  • 제품 설명
    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
  • Manufacturer

Manufacturer

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