Events

Device Recall The Elekta Synergy System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Elekta, 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
    58874
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3079-2011
  • 사례 시작날짜
    2011-05-06
  • 사례 출판 날짜
    2011-08-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100456
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
  • 원인
    A small number of the modular reverse diodes (d1a), a component in the equipment room of the elekta linear accelerator, have ruptured.
  • 조치
    ELEKTA sent an IMPORTANT NOTICE (FCO 20000103022), dated May 6, 2011. The notice identified the product, the problem, and the aciton to be taken by the customer. Elekta recommended that service personnel always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. Elekta also recommended that users make sure that the modulator cover is installed when the digital accelerator is in operation. Elekta will release a Field Change Order when a corrective action is identified.

Device

Device Recall The Elekta Synergy System
  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
    Radiology Devices
  • 유통
    Nationwide and Puerto Rico
  • 제품 설명
    Elekta Synergy || The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • 제조사 주소
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    USFDA