Ultrasound system, imaging, cardiovascular 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 GE Vingmed Ultrasound AS 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
    21236
  • 사례 시작날짜
    2017-03-20
  • 사례 국가
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • 원인
    The manufacturer has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where dicom worklist search response time is slow. this issue is limited to certain vivid ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. if not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam.
  • 조치
    Software to be upgraded

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Vivid E95/E90/E80 with software version 201, revision 54.0 and 61.0, Vivid S70/S60 with software version 201, revision 55.0 and 63.0, Vivid S70N/S60N with software version 201, revision 63.0
  • Manufacturer

Manufacturer