Commercial name of the product: PCR Eleva /// Registration number: 10216719006 /// Models affected: S / S Plus / S Hi-res / Cosimax / Corado / Compact /// Serial number affected: 36626334./// Class risk of the product: I. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Medical Systems DMC GmbH / Philips Medical Systems (Lagoa Santa). 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
    1983
  • 날짜
    2016-09-16
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    Philips plans to replace the system's power supply unit of the Compano Basic PCR scanner, which will eliminate this problem. A Philips Maintenance Engineer will contact you as soon as the Action Kit is available to be implemented. /// If you need to communicate with Philips about this program, please refer to Amendment Request 73200037./// If you need more information or support for this issue, please contact our Philips Solution Center through telephone 0800-701-7789. Service from Monday to Saturday from 07h to 19h.
  • 원인
    A faulty component of the compano reader's power supply may cause the power supply to burn and produce smoke in the compartment.
  • 조치
    Field classification: Field correction by replacing the power supply unit of the PCR reader system Basic affected /// Field action code: FCO73200037 /// Recommendations to users and patients: The system can be used in accordance with the Instructions for Use without restrictions. In case of fire, the user may alert the fire department, use an extinguisher and / or evacuate the premises.