Events

ARIA for Radiation Oncology and ARIA Oncology Information System for Radiation Oncology, Versions10.X, 11.X, 13.0 or 13.5 with Clinical Assessment licence only 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Varian Medical Systems Australasia Pty Ltd 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
    RC-2015-RN-00988-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-10-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00988-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    An anomaly that has been 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. there have not been any reports of patient injury due to this issue.
  • 조치
    Varian is contacting all customers potentially affected by this anomaly with the temporary workaround and will provide regular reports to listing the potentially affected prescriptions. This documentation will be provided to the customer until a verified solution has been installed. Varian is developing a technical correction for this issue. Customers will be contacted by a Varian Field Service Representative when this correction is available to schedule its installation.

Device

ARIA for Radiation Oncology and ARIA Oncology Information System for Radiation Oncology, Versions...
  • 모델명 / 제조번호(시리얼번호)
    ARIA for Radiation Oncology and ARIA Oncology Information System for Radiation Oncology, Versions10.X, 11.X, 13.0 or 13.5 with Clinical Assessment licence onlySerial Numbers: HIT0739M, HIT0968, HIT1044, HIT1172M, HIT1390, HIT1421, HIT1599M, HIT1649, HIT2083, HIT2129M, HIT2263M, HIT2535, HIT2620, HIT2724, HIT3692, HIT3700, HIT4526M, HIT4909ARTG Number: 132638
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd