Events

X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY. Anvisa Registry No. 10216710193. Affected units: EP16E100069, EP16E110084, EP16E110014, EP16E110044, EP16E110083, EP16E110012, EP16E110021, EP16E110008, EP16E110070, EP16EB110003, EP16EB110004, EP16EB110005 and EP16EB110006. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda. 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
    1190
  • 날짜
    2012-10-05
  • 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
    According to the company, if the oil accumulator or other parts are released and the Gantry covers are open while the appliance is in maintenance mode, the maintenance engineer may be struck by the accumulator of ejected oil or other parts. The company's forecast is to terminate the action on 03/22/2012.
  • 원인
    A bolt that secures the oil accumulator inside the gantry may fail, resulting in the separation of the oil accumulator from the tube mounting inside the gantry.
  • 조치
    Check your inventory if you have the affected products, if so, carefully read the instructions in the Alert of the product registration holder (Philips Medical Systems Ltda) and, if necessary, contact the company. The equipment serial number is located on the back of the Gantry. Detailed information to identify your system is available in Appendix B of the Alert Message posted by the company - www.xxxxx.

Device

X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY. Anvisa Registry No. 10216710193. Affected units: EP16E1...

Manufacturer

Philips Medical Systems Ltda.
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA