Events

Device Recall Interplant 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Computerized Medical Systems Inc 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
    58228
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2622-2011
  • 사례 시작날짜
    2008-12-01
  • 사례 출판 날짜
    2011-06-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98759
  • 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
    Interplant software: if the trajectory needle with a non-zero retraction is adjusted in any of the planning views (transverse, 3d) and the program is closed and reopened, the needle definitions page in the dose plan summary (plan view) displays the needle with a 0.00 retraction even when the needle is displayed correctly in the planning view. if the eliminate leading spacers function is applied t.
  • 조치
    Computerized Medical Systems, Inc. sent a "CUSTOMER ADVISORY" letter dated December 1, 2008, to all affected customers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to discontinue use of the product. There is no workaround at this time. This issue was resolved in Interplant Release 3.4.1 software. All possibly affected users have been shipped the Interplant Release 3.4.1 software in May 2010. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.

Device

Device Recall Interplant
  • 모델명 / 제조번호(시리얼번호)
    Interplant Release 3.4.0
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including states of: CA, KS, KY, MA, MD, ME, MO, NC, NE, NY, OH, PA, TX and VA and countries of: Australia, Brazil, Chile, China, Germany and Japan.
  • 제품 설명
    Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 || Used when planning and performing prostate brachytherapy implant procedure. It provides ultrasound probe alignment and radioactive seed implantation.
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • 제조사 주소
    Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    USFDA