Events

Device Recall GammaMed Flexible Applicator 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
    59388
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3013-2011
  • 사례 시작날짜
    2011-07-13
  • 사례 출판 날짜
    2011-08-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102571
  • 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
    Radionuclide System Applicator, Remote-Controlled - Product Code JAQ
  • 원인
    Certain gammamed flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
  • 조치
    Varian Medical Systems, Inc. sent out Customer Technical bulletins in August 2008 and Urgent Medical Device Correction/Urgent Field Safety Notices on July 13, 2011 to all affected customers. The letter included description of device and problem. The current notice supplements and modifies previous instructions and ask that they stop using any flexible applicator probes in inventory. They are to be returned to Varian Brachy Therapy for replacement. Letter go on to list possible scenarios if the length deviation is not detected and advised all personnel working in the radiotherapy department should be notified of the recall. For additional information contact (800) 360-7909.

Device

Device Recall GammaMed Flexible Applicator
  • 모델명 / 제조번호(시리얼번호)
    Lots D01 to H14; Part number GM1102560
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Nationwide (USA) and including the countries of France, Germany, India, Trinidad and Tobago, United Kingdom, Canada, Nepal, Ukraine, Czech Republic, Bangladesh, Thailand, Turkey, Brazil, Estonia, Switzerland, Russia, Greece, Philippines, Spain, Belgium, Kuwait, Romania, Morocco, Mexico, Columbia, Austria, Poland, Kazahstan, Vietnam, Cyprus, New Zealand, Dominican Republic, Norway, Uzebestan, Hungary, Lebanon, South Africa, South Korea, Slovenia, Venezuela, Serbia, Tunisia, Pakistan, Macedonia, Ireland, Azerbajian, Ukraine, Morroco, Italy, Singapore, Nambia, Turkey, Sudan, and Taiwan.
  • 제품 설명
    GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF. || Varian Medical Systems, Palo Alto, CA. || Mfg by Varian Medical Systems, Haan GmbH. || Flexible Applicator Robes are designed for brachytherapy intracavitary treatments in areas such as vagina, vagina stump or rectum.
  • 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