Events

Commercial Names: CT Scanning System / Ingenuity CT; ANVISA registration numbers: 10216710191/10216710209; Risk class: III; Affected models: Brilliance 64, Ingenuity Core, Ingenuity Core128; Affected serial numbers: 10782, 10768, 10777, 10770, 10769, 95839, 95841, 95840, 95866, 95847, 95863, 95846, 95846, 320113. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. / 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
    1892
  • 날짜
    2016-05-06
  • 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
    Philips Healthcare is implementing the software version 3.5.5 upgrade to correct the problem described above. Solution Center will contact you to schedule the software update installation on your site. If you need more information or support for this issue, please contact our Solution Center at 0800-701-7789. Service from Monday to Saturday from 07 to 19h.
  • 원인
    Philips healthcare received field reports stating that certain brilliance 64, ingenuity core and ingenuity core128 systems running software version 3.5.4 exhibited intermittent swirl-like circular artifacts that may appear on rebuilt images and may diagnosis of affected images. the clinician should apply clinical judgment to determine if the images contained in the data set without artifacts contain enough information to make a diagnosis. if these images are sufficient, no action is required. if the images are not sufficient, a new patient scan may be required.
  • 조치
    Action code FCO72800597. Software update

Device

Commercial Names: CT Scanning System / Ingenuity CT; ANVISA registration numbers: 10216710191/102...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. / Philips Medical System...
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA