ARIA PRACTICE MANAGEMENT - 4D INTEGRATED TREATMENT CONSOLE (4DITC) 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
    42986
  • 사례 위험등급
    II
  • 사례 시작날짜
    2011-06-29
  • 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
    Under certain specific circumstances the gantry rotates in the opposite direction to that specified according to the plan parameters when moving from one field to the next. if the patient couch or other medical equipment isi n the path of the gantry damage to property or injury to a patient could occur. according to varian iec scale the gantry will rotate clockwise (cw) from 0.0 degrees to 180.0 degrees and counterclockwise from 0.0 degrees to 180.0e degrees. by default when a user creates an opposing field within a plan that contains static fields the gantry rotation is set to rotate in the clockwise direction. for situations when that is not desired a user activated extended angle flag is provided to cause the gantry to rotate in a counterclockwise direction.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: V8.8 (Lot serial: >10 Serial numbers.); Model Catalog: V8.6 (Lot serial: >10 Serial numbers.); Model Catalog: V8.1.2 (Lot serial: >10 Serial numbers.); Model Catalog: V8.8 (Lot serial: Contact manufacturer.); Model Catalog: V8.6 (Lot serial: Contact manufacturer.); Model Catalog: V8.1.2 (Lot serial: Contact manufacturer.)
  • 제품 설명
    Aria Practice Management - 4D Integrated Treatment Console (4DITC)
  • Manufacturer

Manufacturer