Events

Nuclear Imaging System, Models: Millennium VG and Discovery VH, Record: 10310650051, Risk class III, Affected serial numbers: All model configurations .///. Gamma Camera for Nuclear Medicine Apex-VariCam, Model: APEX-VARICAM, Record: 10306980014, Serial numbers affected: All model settings. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil; GE Medical Systems, LLC 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
    1537
  • 날짜
    2015-03-12
  • 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 company information the products affected by this field action are not at risk unless the collimator nuts have been loosely loosened during a maintenance intervention. This loosening of the nuts without a proper re-tightening is considered a technical error of the service provider. In case of collimator fall, there is possibility of permanent damage or fatal injury. However, to date, reports of adverse events have no record of collimator / injury falls during clinical use of the equipment.
  • 원인
    During the quality control check, a collimator of the vg system collapsed while the detectors were in rotation. there is no record of collimator fall during clinical use of the equipment.
  • 조치
    It is company guidelines that the operator should monitor the patient and the system throughout the scan procedure. In case of collimator detachment, pull the Table Patient Release Handle to remove the patient as indicated in the User Manual. If difficulties or errors arise with the collimator exchange procedure, the operator's manual informs the "collimator change" in the chapter on safety and regulatory information, stating that: "the collimators must be installed properly and secured firmly. Every time after mounting a new collimator set on the head and before performing a scan, rotate the gantry in full rotation (360 °) at least without a patient on the table to check that the collimators are firmly anchored in place ... ". If you have any questions, please contact GE Technical Assistance. /// Attempt to use the most up-to-date version of the Service Manual and Preventive Maintenance procedure (see link: http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library). //// GE Healthcare Technical Assistance will inspect all affected systems to verify that the collimator trolleys and locking mechanisms are operating safely and meet all specifications.

Device

Nuclear Imaging System, Models: Millennium VG and Discovery VH, Record: 10310650051, Risk class I...

Manufacturer

GE Healthcare do Brasil; GE Medical Systems, LLC