Events

Device Recall CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Accuray 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
    60437
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0382-2012
  • 사례 시작날짜
    2011-11-07
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105406
  • 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
    User facility reported an anomaly where inhale and exhale ct pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery.
  • 조치
    Accuray sent a Urgent Medical Device Correction letter dated November 7, 2011, via Federal Express to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The information provided in this letter will be incorporated in user manuals shipped with the CyberKnife system. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at 1. (877) 668-8667 ( USA) 1. (408) 716-4700 ( non USA )

Device

Device Recall CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option.
  • 모델명 / 제조번호(시리얼번호)
    Model number: PN 032384
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA ( nationwide ) including the states of FL, TN, IL, NJ, CO, PA, MD, CA, MS, MN, SC, WA, OK, GA, AZ, and TX., and the countries of France and United Kingdom.
  • 제품 설명
    CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. || The CyberKnife treatment is indicated for the treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • 제조사 주소
    Accuray Incorporated, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • 제조사 모회사 (2017)
    Accuray Inc
  • Source
    USFDA