Events

ultrasound system ARIETTA Prologue 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Hitachi, Ltd. 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
    Field Safety Notice
  • 날짜
    2017-06-07
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Operation of arietta prologue becomes unstable due to contact failure between backend unit (be, screen side) and frontend unit (fe, probe connection side). this may cause the following malfunctions: - the monitor of be is once disappeared and return to the home screen display. - the connection of probe isn’t recognized. - it doesn’t charge the battery of be in spite of setting the battery cutoff switch to enable mode. - it doesn’t charge the battery of be in spite of setting the battery cutoff switch to enable mode. - although fe and be are connected as wired communication, it is recognized as wireless and an alarm would occur. - it would stop the scanning during the examination and returns to the home screen display. - it would freeze the ultrasound image during the scanning (screen update would stop). ' - the communication between fe and be would be lost and fe will finally shut it down. - a hardware error message would be displayed when the machine boots up.

Device

ultrasound system ARIETTA Prologue
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Hitachi, Ltd.

Manufacturer

Hitachi, Ltd.