Events

VESA 75 / 100 adaptation with rotation 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 ITD GmbH 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
  • 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
    We have within the framework of our ongoing quality checks unfortunately ascertained that in the case of the article "vesa 75 / 100 adaptation with rotation", which is part of our monitor mounts and support arms, the riveting of the rotation may possibly not have been carried out according to the specifications. in exceptional cases, it can lead to a loosening thereof, respectively to a loosening of the connection plate in the case of continuous use, which can in turn lead to a risk to patients, users or third parties. for this reason we have decided to carry out a replacement action. on account of the fact that no case of damage has hitherto occurred in practice, this relates to preventive measure with regard to our deliveries, for the limited time period from may to november 2015. based on our records, we have discerned that you have been supplied by us, with the affected products, during the aforementioned time period. a detailed list of relevant orders can be found in an annex to this letter. .

Device

VESA 75 / 100 adaptation with rotation
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    ITD GmbH

Manufacturer

ITD GmbH
  • 제조사 모회사 (2017)
    Itd Gmbh
  • Source
    AMPMDRS