Events

GammaMed Flexible Applicator Probe 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
    59856
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0295-2012
  • 사례 시작날짜
    2008-08-05
  • 사례 출판 날짜
    2011-11-30
  • 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=103877
  • 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
    Gammamed flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
  • 조치
    Varian Medical Systems, Inc. sent a Customer Technical Bulletin CTB-GM-603A on August 5, 2008 to all affected customers. The letter included description of device and problem. The bulletin also advised that if they find that the applicator and source guide tube combination is not within the indicated range on the length gauge, to call VBT technical support using the contact information on page 5 of the bulletin to obtain a replacement applicator probe. Customers are to complete and return the attached verification card. If support is needed the letter provides customer support contact information.

Device

GammaMed Flexible Applicator Probe
  • 모델명 / 제조번호(시리얼번호)
    Part number GM11002560, Lots E01 to H14
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide): Arkansas,California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Montana, Michigan, Missouri, Nebraska, Mississippi, New Jersey, Nevada, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin, and the countries of Austria, Azerbaijan, Brazil, British Columbia, Canada, Chile, Germany, Greece, India, India, Ireland, Israel, Mexico, Morocco, Pakistan, Poland, Republic of Macedonia, Russia, Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Ukraine, and Venezuela.
  • 제품 설명
    GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. || Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.
  • 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