Events

Commercial name: Ultrasound Diagnostic System ACUSON //. Technical Name: Ultrasound Apparatus //. ANVISA Registration No. 10345162017 //. Risk class: II (Medium Risk) //. Serial numbers: 203148; 205101; 205242; 206678; 206819; 206857; 207039; 207574; 207636; 207842; 207923; 207988; 208130; 208132; 208135; 208179; 208332; 208548; 208676; 208678; 208837; 208873; 208904; 208942; 209048; 209088; 209120. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A; Siemens Medical Solutions USA Inc 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
    1965
  • 날짜
    2016-08-03
  • 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
    Recommendation to users and patients: - do not use 6C1 HD and 18L6 HD transducers with CIVCO biopsy connectors for guided biopsy procedures. - do not reposition the region of interest of the Virtual Touch IQ from the original location (default). SEE TECNOVIGILANCE ALERTS: 1649; 1673 If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AEs) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • 원인
    Siemens healthcare diagnósticos sa informs that the field action us006 / 16 / s consists of the software update. when using the equipment with the outdated software it is possible that: - when using the civco biopsy connectors in combination with the acuson s family screen orientations. the path of the biopsy needle may not match the orientation of the screen. this occurs on 6c1 hd and 18l6 hd transducers (alert 1673). - when repositioning the region of interest of the virtual touch iq from its original location (default), the lateral position of the measuring tool (indicated in yellow) may not be in line with the lateral position of the shear rate data (alert 1649).
  • 조치
    Field Action No. US006 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA The Field Action deals with field correction, software update, upon previous sending of letter to the client. Recommendation to users and patients: - do not use 6C1 HD and 18L6 HD transducers with CIVCO biopsy connectors for guided biopsy procedures. - do not reposition the region of interest of the Virtual Touch IQ from the original location (default).

Device

Commercial name: Ultrasound Diagnostic System ACUSON //. Technical Name: Ultrasound Apparatus //....

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Medical Solutions USA Inc