Events

Allura Xper Angiography Equipment Angiography Equipment Angiography Equipment ANVISA Registration Number: 10216710153 Hazard Class: III Model Affected: Allura Xper FD10 Ceiling / Allura Xper FD10 Ceiling / Allura Xper FD20 Ceiling / Allura Xper FD20 Floor / Allura Xper FD10 OR Table / Allura Xper FD20 OR Table Serial numbers affected: 1330; 1308. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V. 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
    2279
  • 날짜
    2017-04-25
  • 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
    Failure to emit the audible alarm occurs very intermittently. The user should always observe the real-time dose information and cumulative fluoroscopy time provided by the system. The fault condition is reset when the case of a new patient is started or when the system is reset. #### Update of the field action: UPDATED ON 12/11/2017, the company presented the completion report of the field action, with sending of necessary evidences and corrective actions.
  • 원인
    Philips healthcare has identified, through customer complaints and internal testing, an intermittent electronic defect in the product. under certain circumstances, a software error may lead to a situation where the five-minute fluoroscopy beep is not emitted as required in 21cfr1020.32 (h) (2) (ii) and iec 60601-2-54 , clause 203.6.2.1.C. no injuries attributed to the problem were reported.
  • 조치
    Field Action Code FCO72200350 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will make correction in the field.

Device

Allura Xper Angiography Equipment Angiography Equipment Angiography Equipment ANVISA Registration...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA