TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT 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
    105845
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-05-16
  • 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
    The 4ditc ad-hoc imaging ciao (complete irradiated area outline) calculation results in a ciao shape that differs from the ciao calculated in ariachart eclipse offline review and on-board imager. the 4ditc algorithm adds dose for the control point at the field edge which should not be added according to the system specifications. this error will be present in the 4ditc mlc display. the discrepancy is a display issue that is only seen when an ad-hoc image template has been added after the plan has been loaded on the 4ditc. if the 4ditc generated ciao image is projected on the patient using the light field the incorrect field edge will be displayed. if the field edge is used to set-up another abutting treatment field the area between the projected field edge and the abutting field edge would be mismatched and not treated.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: TRUEBEAM (Lot serial: H191044); Model Catalog: TRUEBEAM (Lot serial: H191069); Model Catalog: TRUEBEAM (Lot serial: H191071); Model Catalog: TRUEBEAM (Lot serial: H191038); Model Catalog: TRUEBEAM (Lot serial: H191074); Model Catalog: V8.8 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.6 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: V8.8 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: V8.6 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.1.2 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.1.2 (Lot serial: >10 SERIAL NUMBERS.)
  • 제품 설명
    TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT
  • Manufacturer

Manufacturer