Events

GammaMed 12i Accessory 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems, Inc. Oncology 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
    60231
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0330-2012
  • 사례 시작날짜
    2011-10-06
  • 사례 출판 날짜
    2011-12-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104834
  • 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
    The product models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.
  • 조치
    Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION LETTER/FIELD SAFETY NOTICE" letter dated October 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Contact the Varian Help Desk at 1-888-827-4265 for questions regarding this notice.

Device

GammaMed 12i Accessory
  • 모델명 / 제조번호(시리얼번호)
    CODES:   H630164 ,H630703 ,H630727 ,H630756 ,H630787 ,H630810 ,H630829 ,H630850 ,H630868 ,H630888 ,H630165 ,H630705 ,H630728 ,H630757 ,H630789 ,H630811 ,H630832 ,H630851 ,H630869 ,H630889 ,H630168 ,H630706 ,H630729 ,H630758 ,H630790 ,H630812 ,H630833 ,H630852 ,H630870 ,H630891 ,H630170 ,H630711 ,H630732 ,H630760 ,H630792 ,H630813 ,H630834 ,H630854 ,H630871 ,H630892 ,H630205 ,H630712 ,H630733 ,H630764 ,H630793 ,H630814 ,H630835 ,H630855 ,H630872 ,H630895 ,H630206 ,H630713 ,H630736 ,H630769 ,H630794 ,H630815 ,H630837 ,H630857 ,H630877 ,H630896 ,H630210 ,H630714 ,H630737 ,H630771 ,H630795 ,H630817 ,H630839 ,H630858 ,H630878 ,H630897 ,H630211 ,H630716 ,H630739 ,H630774 ,H630798 ,H630818 ,H630841 ,H630859 ,H630879 ,H630898 ,H630214 ,H630718 ,H630741 ,H630776 ,H630801 ,H630820 ,H630842 ,H630860 ,H630880 ,H630901 ,H630215 ,H630719 ,H630744 ,H630777 ,H630802 ,H630822 ,H630843 ,H630863 ,H630881 ,H630902 ,H630216 ,H630720 ,H630747 ,H630778 ,H630804 ,H630825 ,H630845 ,H630864 ,H630884 ,H630903 ,H630219 ,H630721 ,H630749 ,H630781 ,H630807 ,H630826 ,H630847 ,H630866 ,H630885 ,H630904 ,H630701 ,H630722 ,H630753 ,H630784 ,H630809 ,H630828 ,H630848 ,H630867 ,H630886
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide).
  • 제품 설명
    Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH, || Bergische Strasse 16, D-42781 Haan, Germany. || The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • 제조사 주소
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • 제조사 모회사 (2017)
    Varian Medical Systems Inc
  • Source
    USFDA