Events

On Board Imager / VARIAN RADIOTHERAPY SYSTEM with CBCT, Versions 1.4, 1.5 and 1.6 with CBCT 2.1.05 SP1-SP6, registration 10405410011, risk class III, lots / series H074200; H073676; H074373; H074390; H070897; H071472; H071657; H070418; H074494; H073721; H073249; H072087; H071455; H074151; H074298. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Varian Medical Systems Brasil Ltda.; Varian Medical Systems INC 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
    1830
  • 날짜
    2016-02-29
  • 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
    Reinforced the need to adopt the following instructions: OBI version 1.5 and OBI 1.6: Navigate to the OBI application and select the "Cancel" button. The cancellation process can take anywhere from 5 to 30 seconds to complete. Restart the CBCT * acquisition process (See document CP-22609 in its entirety). OBI Version 1.4: Disable the CBCT field on the 4DITC workstation. Restart the OBI computer (s) and Reconstructor. Restart the OBI application. Enable the CBCT field on the 4DITC workstation. All versions of OBI: Contact your local Varian Medical Systems service department to report an incident of CBCT acquisition failure. #### UPDATED ON 08/24/2017, the company sent a completed action report of the field proving that a correction has been made as expected.
  • 원인
    Varian has received numerous reports on the locking of the acquisition of the on-board imager® cone beam ct [cbct] that prevents the reconstruction of the image. a repeat of the scan is required. there are two possible symptoms: 1) the cbct application stops updating the display during acquisition. 2) an exception occurs during acquisition. although the cbct projections have been acquired, it will not be possible to generate the reconstructed cbct and the scan must be repeated. varian company describes that no administration failures or injuries were reported due to this problem.
  • 조치
    Action code CP-22609. Send security warning to all affected clients.

Device

On Board Imager / VARIAN RADIOTHERAPY SYSTEM with CBCT, Versions 1.4, 1.5 and 1.6 with CBCT 2.1.0...

Manufacturer

Varian Medical Systems Brasil Ltda.; Varian Medical Systems INC