Events

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 028 05 16 000
  • 사례 시작날짜
    2016-05-04
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9303
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    The following issues have been found in mx 16-slice systems with software version 1.1.4.21426: 1. during the filming operation on mx16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. if the operator fails to copy the current patient’s images before pasting, a previous patient’s images may be present in the clipboard and be copied onto the film of the current patient. 2. during the bolus tracking scan, if the auto voice in tracker scan is enabled, the tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started. 3. if the scan protocol with sas (spiral auto start) function is selected to plan the scan, the sas option may not be displayed on the contrast tab of the scan protocol parameter area or the sas option is displayed but not enabled as pre-configured in the protocol. this issue only occurs on the first helical scan after system startup that applies sas function. (the issue will not occur on the following scan if any helical scan has been executed after system startup.).

Device

MX 16-slice CT Systems
  • 모델명 / 제조번호(시리얼번호)
    software version v1.1.4.21426
  • 제품 설명
    Computed tomography x-ray system
  • Manufacturer
    Philips Healthcare

Manufacturer

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