Events

Device Recall RoboCouch Patient Positioning System 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
    64809
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1155-2013
  • 사례 시작날짜
    2013-03-27
  • 사례 출판 날짜
    2013-04-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117112
  • 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
    Couch, radiation therapy, powered - Product Code JAI
  • 원인
    A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the robocouch manipulator may be defective.
  • 조치
    Accuray issued an Urgent Advisory Notification letter dated March 27, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Field Service Engineers will be replacing the affected product. Questions and concerns are to be directed to Accuray Customer Support at 1-877-668-8667

Device

Device Recall RoboCouch Patient Positioning System
  • 모델명 / 제조번호(시리얼번호)
    Model number: 025007
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide including the states of: OH, MO. OK, CA and VA and the countries of: Finland, France, Luxembourg, Poland, Russia, Turkey and Japan.
  • 제품 설명
    RoboCouch Patient Positioning System || Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
  • Manufacturer
    Accuray Incorporated

Manufacturer

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