Events

ACUSON Ultrasound Diagnostic System Technical Name: Ultrasound Apparatus ANVISA Registration Number: 10345162017 Hazard Class: II Affected Model: ACUSON S1000, ACUSON S2000, ACUSON S3000 Series Affected Numbers: 201092, 201936, 202290, 202295 , 202352, 202637, 203198, 203217, 203217, 203217, 203217, 203282, 203531, 203535, 203549, 203559, 205259, 205260, 205262, 205282, 205344, 205494, 205521, 205572, 205651, 205701, 205750, 205876, 206270 , 206756, 206984. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics 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
    2090
  • 날짜
    2016-10-24
  • 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
    To avoid the problem of misalignment of the transducers the recommendation is not to use the 6C1 HD and 18L6 HD transducers with the CIVCO biopsy connectors for guided biopsy procedure. Guided procedures should be performed with other transducers as stated in the "Instructions for Use" of the equipment. To avoid the problem of repositioning Virtual Touch IQ, you should not reposition the region of interest of the original location (default).
  • 원인
    The company has identified in acuson s family systems that both the 6c1 hd transducers and the 18l6 hd transducers demonstrate an alignment error when using the screen orientations. this problem occurs 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. a possible measurement error on the acuson s family ultrasound system when repositioning the virtual touch iq region of interest from its original (standard) location is also described, the lateral position of the measuring tool may not be in line with the lateral position of the shear velocity data.
  • 조치
    Field Action Code US007 / 16 / S triggered under the responsibility of the company Siemens Ltda. Company will make correction in the field.

Device

ACUSON Ultrasound Diagnostic System Technical Name: Ultrasound Apparatus ANVISA Registration Numb...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc.