Events

Flexible Implant tube 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems 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
    31941
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0921-05
  • 사례 시작날짜
    2005-04-14
  • 사례 출판 날짜
    2005-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-08-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38785
  • 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, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
  • 원인
    A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
  • 조치
    The recalling firm notified end users by Customer Technical Bulletin on 4/14/05. The bulletin advised of potential for the blind end of the implant tube to become separated with the possible effect of the tube end being inhaled by a patient. Consignees were instructed to stop using product and return for replacement. The firm''s bulletin is also available on the company website.

Device

Flexible Implant tube
  • 모델명 / 제조번호(시리얼번호)
    Lot 04/21/1
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to direct accounts in CT, MI, PA, CO, VT and MO. Product was additionally sold to foreign accounts in internationally.
  • 제품 설명
    Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or contained in the Flexible Interstitial Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems
  • 제조사 주소
    Varian Medical Systems, 700 Harris Street, Suite 109, Charlottesville VA 22903-4584
  • Source
    USFDA