translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Philips Healthcare 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 075 08 14 001
  • 사례 시작날짜
    2014-08-19
  • 사례 국가
  • 사례 출처
    SFDA
  • 사례 출처 URL
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
  • 데이터 추가 비고
    Report Source: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129099
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Problem 1: when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application, the ejection fraction (ef) displayed should be the same as the ejection fraction (ef) originally displayed when the bookmark was first created. in some instances, the ejection fraction (ef) may be different. problem 2: when processing using one of the following nm clinical applications: autoquant, emory cardiac toolbox, corridor4dm, or neuroq, the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. note: the data presented to the reviewing physician is the data for the patient presented by the application labeling. problem 3: while using the nm viewer application, an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out. problem 4: while displaying pet images within ct viewer, the suv results displayed may be calculated with an suv method different from the one specified in system preferences. this issue affects the ct viewer and multi- modality tumor tracking applications. the expected behavior in such a case is that the application displays a warning that suv cannot be calculated due to missing information, and the images are displayed with the original acquisition units (bq/ml). instead, in affected systems, if the patient height has not been entered and the selected suv calculation method requires height data (i.E., suv-bsa), the system may display an suv calculated using a different method (suv-bw) without providing any warning that required data had not been entered or informing the user of the change.

Device

  • 모델명 / 제조번호(시리얼번호)
    - IntelliSpace Portal DX/HX/EX, Software Versions 5 and 6 - IntelliSpace Portal IX, Software Versions 5 and 6 - IntelliSpace Portal LX SPECT, Software Versions 5 and 6 ………………………………….. Update code from FDA : - Please check attached file for lot numbers –
  • 제품 설명
    Workstations for Medical Imaging Systems
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • 제조사 대표
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA