Events

NITROGEN MONITORS / LOCATOR / NERVE STIMULATORS NUMBERS FJ960184, 120, 132, 134, 137, 142, 144, 166, 0001-1014, 0003-1015, 9909-1001, 9910-1000, 9910-1002, 9910-1005, 9910-1006, 9910-1007, 9911-1008, 9911-1009, 9911-1011, 9912-1012, 9912-1013 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 NEUROSOFT 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
    28
  • 날짜
    2001-05-14
  • 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
    The electrical safety of the above monitors does not comply with international standards as declared in the marketing registry. neurosoft declares that the potential of electrical shock on the operator or patient is increased. the level of gravies.
  • 조치
    THE MANUFACTURER STARTED WITHDRAWN IN. VERIFY THAT YOU HAVE RECEIVED THE NEUROSOFT LETTER OF OCTOBER 20, 2000. IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. REPORT USERS AND MAINTENANCE MANAGERS IN YOUR ESTABLISHMENT OF THE ALERT WITH THESE MONITORS AND DO NOT USE THEM. NEUROSOFT MUST REPLACE THEM BY MONITORS CONFORMING TO THE RULES. IF YOU ARE SUSPECTED THAT THERE WERE AGGRAVATIONS ASSOCIATED WITH THE USE OF YOUR A3000 SYSTEM, CONTACT THE NEUROSOFT TECHNICAL OFFICER BY PHONE 0021-1-703-904-7875. NEUROSOFT MUST AGENDE THE REPLACEMENT OF COMPONENTS NOT CONFORMING TO YOUR ESTABLISHMENT.

Device

NITROGEN MONITORS / LOCATOR / NERVE STIMULATORS NUMBERS FJ960184, 120, 132, 134, 137, 142, 144, 1...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    NEUROSOFT INC.

Manufacturer

NEUROSOFT INC.
  • Source
    ANVSANVISA