Events

Device Recall Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp. 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
    63856
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1103-2013
  • 사례 시작날짜
    2012-12-10
  • 사례 출판 날짜
    2013-04-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114917
  • 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
    System, planning, radiation therapy treatment - Product Code MUJ
  • 원인
    Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from xknife using dicom-rt.
  • 조치
    Integra initiated a voluntary recall on December 10, 2012 by providing a written Urgent: Medical Device Recall Notification to US consignees who have experienced the software issue due to the configuration of their system. The letter identifies the affected product, as well as, advises customers of the nature of the issue and how it affects treatment records. - Advises customers that they will be contacted when V 5.0.3 software, where the software error has been addressed, is available to schedule an upgrade. - Requests that customer consignees complete and return the Product Recall Acknowledgment Form. If customer have additional questions, they should contact the firm's service hotline at 1-888-772-7378.

Device

Device Recall Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning
  • 모델명 / 제조번호(시리얼번호)
    Software Versions 5.0.1 and 5.0.2.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
  • 제품 설명
    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, || Software Versions 5.0.1 and 5.0.2. || Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.