Events

Computed Tomography Fluoroscopic Option Software for Use with the TSX-101A Aquilion and Model TSX-021A Asteion Computed Tomography Scanners: (1) Model TSFX-003A, (2) Model TSFX-003B, (3) Model TSFX-003C 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Toshiba America Medical Systems 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
    177
  • 날짜
    2001-05-10
  • 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
    BRAZIL - 11/21/2001 - THE COMPANY REPORTS THAT THE CORRECTION OF THE PRODUCT WAS OCCURRED BY A BUG OF SOFTWARE RELEVANT TO THE OPTIONAL STUDIED CT FLUOROSCOPY SYSTEM MODEL TSXF-003A, TSXF-003B AND TSFX-003C, THAT MAY BE INCORPORATED IN AQUILION COMPUTERIZED TOMOGRAPHY SYSTEMS TSX-101A AND ASTEION TSX-021A, AND THAT FOR BRAZIL, EQUIPMENT WAS NOT IMPORTED WITH THIS OPTIONAL, BEING EXCLUDED OF CORRECTIVE NECESSARY.
  • 원인
    X-ray generation may occur without command of the operator when an unusual sequence program is used. the importer initiated a recall through correspondence sent on may 10, 2001.
  • 조치
    Make sure that you have received the correspondence sent on May 10, 2001 by Toshiba America Medical Systems (TAMS). Follow the instructions given to avoid the above mentioned problem. New software will be distributed August 31, 2001, to correct the problem. For more information, contact TAMS at (800) 421-1968

Device

Computed Tomography Fluoroscopic Option Software for Use with the TSX-101A Aquilion and Model TSX...

Manufacturer

Toshiba America Medical Systems Inc
  • Source
    ANVSANVISA