Events

1. Acuson Antares Diagnostic Ultrasound System, Registry 10234230070; Series: 115454 /// 2. Aspen Dopple Ultrasonic System, Registry 10234230083; series: 32491 /// 3. Diagnostic system by ultrasonography sonoline G60 S, Registry 10234230086; series: GAA0313 /// 4. Cypress Diagnostic Ultrasound System, trademark Acuson, Registry 10234230097; The present invention relates to a Cardiovascular Ultrasound System CV70, trademark Acuson, registration number 10234230101, series: HAA0355, series: 83108, 73847, 73852, 74567, 75197, 82116, 82170, 82172, 82171, 82300, 80499, 82387, HAU0410, HAA0438, HAA0500, HAA0523, HAA0553, HAA0576 /// 6. Acuson Sequoia Doppler Ultrasonic System, Registry 10234230133, series: 64926, 64656, 64433 /// 7. Diagnostic Acuson X300 Ultrasound System, Registration 10234230141, series: 313087 ; 313098; 313160; 312133; 313-204; 313535; 313524; 313,504; 313529; 313555; 313722; 315272; 315255; 315262; 315297; 315547; 315487; 315588; 315611; 315778; 316036; 316601; 316585; 316680; 316811; 316818; 316866; 317282; 317485; 317545; 340495; 340496; 341851; 341896; 344505; 343232; 344650; 344717; 344723; 344724; 344733; 344734; 344815. /// 8. Diagnostic Ultrasound System Acuson SC2000, Registry 10234230166, series: 400762, 401809 /// 9. Acuson Diagnostic Ultrasound System. Entry 10234230192, series: 202637. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos Ltda.; Siemens Medical Solutios USA 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
    1593
  • 날짜
    2015-05-18
  • 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
    According to the record holder, if the yellow tip protector continues to be used with the V5Ms transducer, its life may be shortened. //////// - 09/07/2015 - According to the company the Field Action was completed.
  • 원인
    The yellow tip protector of the transducer, shipped with the v5ms transducer, when not being used for exams, is covered by this protector. the shield is incompatible with the material covering the articulated portion of such a transducer, by coming into physical contact with one another.
  • 조치
    The registry holder will perform a correction of the use instruction and recommends that users immediately stop using the yellow tip protector. After that, perform the leak test for the transesophageal transducer before each use, following the manufacturer's instructions accompanying the tester. Only use cleaning and disinfection solutions approved by the manufacturer. Use transducer sheaths released for the market and designed specifically for transesophageal applications. When storing the transesophageal transducer, take extreme care to keep the distal tip upright. Never move the distal tip by hand. Always use the flexible controls. If you notice any damage or wear on your transducer, or if the transducer does not pass the leak test, immediately stop its use and contact your local Service Engineer.

Device

1. Acuson Antares Diagnostic Ultrasound System, Registry 10234230070; Series: 115454 /// 2. Aspen...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Medical Solutios USA