Events

Device Recall ViewRay MRIdian 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Viewray Incorporated 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
    73086
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0806-2016
  • 사례 시작날짜
    2015-12-24
  • 사례 출판 날짜
    2016-02-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143035
  • 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
    Accelerator, linear, medical - Product Code IYE
  • 원인
    The system loaded a completion fraction in the incorrect order after a treatment interruption.
  • 조치
    ViewRay sent an Customer Advisory Notice dated December 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Workaround: If you want to move a completion plan to a later date in the Delivery Calendar then do not schedule it until right before you are ready to treat that completion plan. While we will address this issue in the next release of software we recommend that in the event of a completion plan you always review the plan name loaded on the TPDS and verify the remaining time and beams are as expected with the completion plan. If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at support@viewray.com or call the ViewRay" Customer Support center at 855-286- 8875.

Device

Device Recall ViewRay MRIdian
  • 모델명 / 제조번호(시리얼번호)
    Model #: 10000, Serial #'s: 100, 101, 102, 104 & 105
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
  • 제품 설명
    MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
  • Manufacturer
    Viewray Incorporated

Manufacturer

Viewray Incorporated
  • 제조사 주소
    Viewray Incorporated, 2 Thermo Fisher Way, Oakwood Village OH 44146-6536
  • 제조사 모회사 (2017)
    ViewRay, Inc.
  • Source
    USFDA