Events

GammaMed Plastic Needle with Mandrin 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian 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
    59779
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0328-2012
  • 사례 출판 날짜
    2011-12-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103821
  • 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
    Plastic needle tip could possibly crack or separate.
  • 조치
    Varian Medical Systems sent a "CUSTOMER TECHNICAL BULLETIN" letter dated September 30, 2008 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed users to inspect needle tips before and after every clinical application to prevent needle tip separation or cracking.

Device

GammaMed Plastic Needle with Mandrin
  • 모델명 / 제조번호(시리얼번호)
    Part number GM11007580
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of Arizonia, California, Florida, Illinois, Indiana, Michigan, North Carolina, and Vermont, and the countries of Argentina, Austria, Belgium, Canada, Estonia, France, Germany, India, Norway, Pakistan, Russia, Slovenia, So. Africia, Spain, Switzerland, United Kingdom, and Ukraine.
  • 제품 설명
    GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. || The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.
  • 제조사 주소
    Varian Medical Systems, Inc., 700 Harris St Ste 109, Charlottesville VA 22903-4584
  • 제조사 모회사 (2017)
    Varian Medical Systems Inc
  • Source
    USFDA