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Flexilab Laboratory Information System with Access Transcription Stations Anatomic Pathology Lab: (1) Version 5.2, (2) Version 5.23, (3) Version 5.3 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Sunquest Information 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
    343
  • 날짜
    2001-11-23
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    A defect reported above in the laboratory information systems may result in incomplete reporting. the manufacturer has initiated the correction by product safety note number psn-01-l12 dated april 19, may 16 and 23, 2001.
  • 조치
    Please verify receipt of Product Safety Note number PSN-01-L12 dated April 19, May 16 and 23, 2001 from Sunquest Information Systems. If the product is being used, follow the procedures outlined in the note from Sunquest Information Systems. Product repair can be obtained by contacting your local representative or directly with Sunquest Software Distribution at (1) (520) 570-2000 in the United States. For more information, contact Sunquest Information Systems at 1 (520) 382-6170 in the United States. ANVISA is interested in following if there was adequate collaboration of the manufacturer with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Device

Flexilab Laboratory Information System with Access Transcription Stations Anatomic Pathology Lab:...

Manufacturer

Sunquest Information Systems Inc
  • Source
    ANVSANVISA