Events

Device Recall Acuity with Conebeam Computed Tomography 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems Oncology Systems 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
    46919
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1460-2008
  • 사례 시작날짜
    2008-01-03
  • 사례 출판 날짜
    2008-07-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-09-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68508
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Radiation therapy simulation system - Product Code KPQ
  • 원인
    Incorrect image orientation: the image orientation tag may not be set correctly if the patient has been scanned with an orientation other than head first spine. when such images are imported to a treatment planning system, they may appear with either a mirrored or a rotated view.
  • 조치
    Consignees were notified by an Urgent Medical Device Correction letter issued on 02/05/2008. The letter provided recommended actions for users to follow in order to avoid the software error. The letter informed users that a service pack is being created to correct the issue and that the recalling firm will notify users when it becomes available. For additional information, contact 888-827-4265.

Device

Device Recall Acuity with Conebeam Computed Tomography
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: H770002-H780001, H770012-H780058, H770030-H780034, H770055-H780046, H770068-H780010, H770107-H780050, H770113-H780060, H770119-H780035, H770134-H780026, H770143-H780039, H770159-H780062, H770170-H780056, H770184-H780061, H770212-H780074, H770245-H780086 and H770279-H780105.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA including states of CA, MA and PA, and countries of UK, Chile, Belgium, Canada and Germany.
  • 제품 설명
    Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

Varian Medical Systems Oncology Systems
  • 제조사 주소
    Varian Medical Systems Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • 제조사 모회사 (2017)
    Varian Medical Systems Inc
  • Source
    USFDA