Events

Commercial Name: Magnetic Resonance Imaging System Technical Name: Magnetic Resonance Imaging Equipment ANVISA Registration Number: 80071260352 Hazard Class: II Model Affected: Signa Creator; Signa Explorer Affected Serial Numbers: Signa Creator and Signa Explorer Equipment 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Healthcare (Tianjin) Company Limited e GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda. 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
    2139
  • 날짜
    2016-09-09
  • 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
    You may continue to use the system, but you must ensure that the RF power monitor is reactivated when starting a new patient examination if a redefinition of TPS has been performed during the patient examination. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • 원인
    The function of the rf power monitor is to monitor the output power of the rf amplifier and to detect if the power of the rf transmission exceeds the expected amount that is generated. if the output power of the rf amplifier exceeds the specified sar (specific absorption rate), the rf power monitor will stop scanning. ge healthcare has identified that if the user performs a tps (transceiver processing and storage) reset during patient scanning, the rf power monitor is disabled for the remainder of this patient scan. this prevents the power monitor from detecting any subsequent failure of the rf transmission function.
  • 조치
    Field Action Code IMF 67921 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company will make correction in the field.

Device

Commercial Name: Magnetic Resonance Imaging System Technical Name: Magnetic Resonance Imaging Equ...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Healthcare ...