Events

Device Recall TomoHDA(R) 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
    78686
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0289-2018
  • 사례 시작날짜
    2017-11-17
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160118
  • 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
    Uncontrolled couch z-axis movement (descent).
  • 조치
    Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated the following: "Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series software version 2.1.2 (Hi ¿Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem." For questions contact Accuray Customer Support by phoning the regional support lines.

Device

Device Recall TomoHDA(R) System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 110033 110137 110155 110206 110221 110290 110318 110348 110353 110360 110364 110384 110408 110410 110411 110452 110457 110463 110473 110475 110476 110477 110478 110479 110481 110483 110484 110485 110486 110487 110488 110489 110490 110492 110493 110496 110498 110500 110502 110513 110514 110515 110516 110518 110520 110521 110523 110524 110526 110529 110530 110535 110538 110542 110543 110550 110551 110557 110559 110560 110561 110564 110567 110571 110572 110575 110580 110582 110583 110584 110585 110586 110587 110588 110593 110598 110599 110600 110603 110604 110605 110609 110610 110612 110613 110614 110616
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    TomoHDA(R) System, Model Number 1018286 || Product Usage: || The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • 제조사 주소
    Accuray Incorporated, 1240 Deming Way, Madison WI 53717-1954
  • 제조사 모회사 (2017)
    Accuray Inc
  • Source
    USFDA