ARIA RADIATION THERAPY MANAGEMENT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 VARIAN MEDICAL SYSTEMS INC. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    44650
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-10-01
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    An anomaly was identified with the aria for radiation oncology software with a clinical assessment license. admin instructions may not print on drug order prescriptions or be transmitted with e-rx. when the user changes the prescription "type" field after inputting admin instructions in the text box the admin instructions portion of the prescription will not be saved to the database. an e-rx transmitted to the pharmacy will not contain the intended admin instructions. the printed prescription will also not contain the intended admin instructions. this anomaly only occurs for sites that have a clinical assessment license for the aria radiation oncology software / licence set. aria users who do not have a clinical assessment license will not be affected.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 7 9 5 8 5 3 (Lot serial: Contact manufacturer.); Model Catalog: 795853 (Lot serial: >10 serial numbers.); Model Catalog: 7 9 5 8 5 3 (Lot serial: >10 serial numbers.); Model Catalog: 795853 (Lot serial: Contact manufacturer.)
  • 제품 설명
    Aria Radiation Therapy Management
  • Manufacturer

Manufacturer