Events

Magnetic Resonance Imaging Equipment, SIEMENS Brand, Risk Class II, of the following models :. - Magnetom Aera / Magnetom Skya, Registry: 10234230175 ///. - Magnetom Avanto, Registry: 10234230095 ///. - Magnetom Espree, Registry: 10234230115 ///. - Magnetom Essenza and Verio, Registry: 10234230155 ///. - Magnetom Harmony, Registry: 10234230056 (hazard class III) ///. - Magnetom Sonata, Record: 10234230089 ///. - Magnetom Spectra, Registry: 10234230182 ///. - Magnetom Symphony, Registry: 10234230057 ///. - Magnetom Trio, Registry: 10234230098 ///. Serial numbers: attached. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Ltda.; SIEMENS AG Medical Solutions Group. 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
    1515
  • 날짜
    2014-11-24
  • 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
    The holder of the registration informs: "The possibility of a rupture in the quench tube, which may cause the helium gas to leak into the magnetic room or any other area near the quench tube. In rare cases, this helium gas may lead to a displacement of oxygen in the air causing danger by asphyxiation in people in the area. Other hazards, such as freezing, can be caused by the extremely low temperatures of helium gas. #### UPDATED ON 08/21/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • 원인
    Siemens has detected that in some cases siemens magnetom systems with superconducting magnets may have been installed by omitting essential safety requirements for the installation of the quench tube.
  • 조치
    The registration company advises users to wait for the quench tube check by the Siemens team. If, during the inspection, you detect any discrepancies with the requirements of Siemens, the user will be informed separately about the type of divergence together with a plan of how it will be corrected. (SEE ANNEX CUSTOMER LETTER)

Device

Magnetic Resonance Imaging Equipment, SIEMENS Brand, Risk Class II, of the following models :. - ...

Manufacturer

Siemens Ltda.; SIEMENS AG Medical Solutions Group.