Events

Trade name: Optima X-ray system. ANVISA registration number: 80071260245. Risk class: III. . Affected model (s); and Lot (s) / Serial number (s) affected: OPTIMA XR220AMX ... The Optima XR200amx and BRIVO XR285amx X-ray systems (ANVISA Registration 80071260246) are also affected. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE MEDICAL SYSTEMS LLC; GE Healthcare do Brasil 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
    1785
  • 날짜
    2015-01-05
  • 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
    Dropping the arm assembly can result in personal injury to a person. To date, there have been no incidents or injuries reported as a result of this security problem found internally. ### Field Action Update: UPDATED ON 10/23/2017, the company filed the field action completion report verifying the sending the security warning to the client with evidence of science and all actions completed.
  • 원인
    Problem related to the operation of the safety lock of the column that supports the horizontal arm. this safety latch mechanism acts as backup in the unlikely event of the primary safety cable breaking.
  • 조치
    CLASS III - Situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences. / / Field Action: Field Correction - Parts / Parts Correction. /// Field Action Code: IMF 10906./// The system may continue to be used. A GE Healthcare representative will contact the establishments that have equipment affected by this field action to arrange for correction.

Device

Trade name: Optima X-ray system. ANVISA registration number: 80071260245. Risk class: III. . Affe...

Manufacturer

GE MEDICAL SYSTEMS LLC; GE Healthcare do Brasil