Events

Robotic Radiosurgery System CYBERKNIFE 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 ACCURAY INCORPORATED 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
    I1502-64
  • 사례 연번
    2009EBC-0003732
  • 날짜
    2015-02-10
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer states that a software update should be performed for versions 8.0 that have the first generation of variable aperture collimator, since there was no linear relationship between the opening field of the collimator jaws and the size of the beam, an important relationship in the calculation of accuracy of the dose, leading to potentially serious adverse events occurring on the patient.

Device

Robotic Radiosurgery System CYBERKNIFE
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Linear accelerator in high doses to tumors with extreme precision - offers new hope to patients all over the world. CYBERKNIFE systems are intended to provide treatment planning and guided image-guided stereotactic radiotherapy and radiotherapy for tumors, injuries and conditions anywhere in the body when radiation treatment is indicated. These systems can be used for tracheatrocytoma, glioma, tumors of the base of the skull, metastasis, (cerebral and bone), nasopharyngeal carcinoma, meningioma, acoustic neuroma, vertebral and cavernous malformations, trigeminal neuralgia and tumors of the neck and lung.
  • Manufacturer
    ACCURAY INCORPORATED

Manufacturer

ACCURAY INCORPORATED