Events

MAGNETIC RESONANCE IMAGE SYSTEM, Models and records: SEE CUSTOMER LETTER. ///. This fix applies to units of the following GE Healthcare IRM systems: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T , Signa Excite 3.0T, Signa Contour / I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w, Signa Profile and Signa Ovation. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil; GE Medical Systems, LLC 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1540
  • 날짜
    2015-03-13
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    Failure to update the software may result in errors in image orientation. Errors of this nature may result in inaccuracy in treatment.
  • 원인
    As described by the company "as of 12/11/2014 ge healthcare became aware that the latest version of the equipment's current software may not have been reinstalled in some facilities after performing maintenance services that require the software to be recharged . the latest implemented version of the software may include security updates. ".
  • 조치
    According to company information, all affected systems will be inspected and ensured that the appropriate version of the software is installed, free of charge. The systems that allow this action will be checked remotely (online), and will visit the establishments where remote verification is unavailable.

Device

MAGNETIC RESONANCE IMAGE SYSTEM, Models and records: SEE CUSTOMER LETTER. ///. This fix applies t...

Manufacturer

GE Healthcare do Brasil; GE Medical Systems, LLC